Patient Medication Information: uses, side effects, how to take - NTP-Rabeprazole EC
ABOUT THIS MEDICATION
Read this leaflet carefully. It contains general information about NTP-RABEPRAZOLE EC tablets that you should know in addition to the specific advice from your doctor or pharmacist. It is important for you to carefully follow your doctor's instructions regarding how and when to take NTP-RABEPRAZOLE EC tablets.
What the medication is used for:
NTP-RABEPRAZOLE EC is the brand name for a drug called rabeprazole sodium.
The most common uses of NTP-RABEPRAZOLE EC tablets are:
- symptomatic relief and healing of duodenal ulcers;
- symptomatic relief and healing of stomach ulcers;
healing of gastroesophageal reflux disease
(GERD) and relief of its symptoms such as burning sensation rising from the chest towards the neck (heartburn) and the flow of bitter/sour juice into the mouth (regurgitation);
treatment of symptoms (i.e. heartburn and
regurgitation) of non-erosive reflux disease (NERD);
maintenance treatment of gastroesophageal reflux
disease (GERD).
NTP-RABEPRAZOLE EC tablets may also be used in rare conditions like "Zollinger-Ellison syndrome," where the stomach produces large amounts of acid.
When used with certain antibiotics, NTP-
RABEPRAZOLE EC is also used for the treatment of ulcers caused by infection with a bacterium called Helicobacter pylori (H.pylori), and to help reduce the risk of these ulcers from coming back. If the doctor is prescribing therapy with a combination of NTP-
RABEPRAZOLE EC and antibiotics (amoxicillin and clarithromycin) the pharmacist should provide you with information on the antibiotics.
What it does:
NTP-RABEPRAZOLE EC tablets work by reducing the amount of acid made in your stomach.
When it should not be used:
- If you are allergic to rabeprazole, other medications in this class, or to the "nonmedicinal" substances in NTP-RABEPRAZOLE EC tablets (See What the nonmedicinal ingredients are), or to the antibiotics amoxicillin or clarithromycin if these are used with NTP-RABEPRAZOLE EC to treat ulcers caused by H. pylori.
What the medicinal ingredient is:
Each NTP-RABEPRAZOLE EC tablet contains rabeprazole sodium as the medicinal ingredient.
What the nonmedicinal ingredients are:
Each NTP-RABEPRAZOLE EC tablet contains: Ammonium hydroxide, Anatase titanium dioxide, n-butyl alcohol, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hypromellose 15 cP, hypromellose phthalate, industrial methylated spirit 74 OP BP, iron oxide black, isopropyl alcohol, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, shellac glaze, stearic acid, titanium dioxide, triethyl citrate.
The 10 mg also contains iron oxide red and iron oxide yellow in the colour coating, and the 20 mg contains FD&C Yellow #6 aluminum lake and quinoline yellow aluminum lake in the colour coating.
What dosage forms it comes in:
Tablet 10 mg, 20 mg rabeprazole sodium
WARNINGS AND PRECAUTIONS
BEFORE you use NTP-RABEPRAZOLE EC, tell your doctor:
- about all health problems you have now or have had in the past, including liver problems;
- about other medicines you take, including ones you can buy without a prescription (See interactions with this medication)
if you are pregnant, plan to become pregnant, or are breast-feeding.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with NTP-RABEPRAZOLE EC include:
Ketoconazole, digoxin, warfarin , atazanavir.
PROPER USE OF THIS MEDICATION
Your doctor has recommended you take NTP-RABEPRAZOLE EC tablets for a specific number of weeks. Keep taking your NTP-RABEPRAZOLE EC tablets, as recommended by your doctor, until you have finished all your tablets. Do not stop even when you start to feel better. If you stop taking NTP-RABEPRAZOLE EC tablets too soon, your symptoms may return.
NTP-RABEPRAZOLE EC tablets may be taken with or without meals and should be swallowed whole with a beverage, not chewed or crushed.
If you have reflux symptoms with esophagitis: The recommended adult dose is 20 mg once daily. In most patients the healing occurs in four weeks. If not healed, your doctor may recommend an additional four weeks of treatment.
If you have reflux symptoms without esophagitis, such as heartburn and regurgitation:
The recommnended adult oral dose is 10 mg once daily to a maximum of 20 mg once daily in patients without esophagitis. If symptom control is not achieved after four weeks, your doctor may recommend further investigation.
If you have a duodenal ulcer:
The recommended adult dose is 20 mg once daily for up to four weeks. Your doctor may decide to continue treatment to ensure healing depending on your condition.
If you have a stomach ulcer:
The recommended adult dose is 20 mg once daily for up to six weeks. Your doctor may decide to continue treatment to ensure healing depending on your condition.
If you have an ulcer caused by H. pylori infection: The recommended adult dose is 20 mg twice daily used in combination with antibiotic drugs (clarithromycin and amoxicillin) twice daily, preferably with the morning and evening meals, for one week to treat ulcers associated with Helicobacter pylori and to help reduce the risk of these ulcers from coming back.
If you are given NTP-RABEPRAZOLE EC in combination with antibiotic drugs, it is important that you take all medications at the correct time of day and for the entire treatment period, to ensure they will work properly. Studies have shown that patients who take their medications as prescribed, have better ulcer healing rates and greater success in getting rid of their H. pylori infection.
Overdose:
In case of drug overdose, contact a health care practitioner (doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.
Missed Dose:
If you forget to take one dose of NTP-
RABEPRAZOLE EC medication, take a tablet as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all. Never double-up on a dose to make up for the one you have missed, just go back to your regular schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, NTP-RABEPRAZOLE EC tablets may cause side effects in some people. When side effects have been reported, they have been generally mild and did not last a long time. Headache and diarrhea are the most common side effects; less often rash, itchiness and dizziness can occur. If any of these become troublesome, consult your doctor.
If you experience symptoms such as severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking the drug and call your Health care professional immediately.
If you experience any unusual or unexpected symptoms while using NTP-RABEPRAZOLE EC tablets, consult your doctor.
This is not a complete list of side effects. For any unexpected effects while taking NTP-RABEPRAZOLE EC, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your tablets stored at room temperature (15o to 30oC) and protected from moisture. They should be kept in a safe place where children cannot reach them.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance Program by one of the following 3 ways: ------------------------------------------------------------------ $ Report online at
www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345 $ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
Important Note:
This information is intended to alert you to which situations you should call your doctor about. Other situations which cannot be predicted may arise while you are taking medicines. Nothing should stop you from calling your doctor with any questions or concerns you have about using NTP-RABEPRAZOLE EC tablets.
This document plus the full product monograph, prepared for health professionals can be found by contacting NT Pharma Canada Ltd.
at: 1-800-268-4127 ext. 5005 (English Canada) or 1-877-777-9117 (French Canada)
or druginfo@tevacanada.com
NT Pharma Canada Ltd.
5691 Main Street
Stouffville, Ontario
L4A 1H5
Canada