Patient Medication Information: uses, side effects, how to take - PMS-Rabeprazole EC
What is pms-RABEPRAZOLE EC used for?
pms-RABEPRAZOLE EC is used in adults to treat conditions where reducing stomach acid production is needed, such as:
- relieve symptoms and heal duodenal ulcers.
- relieve symptoms and heal stomach ulcers.
heal gastroesophageal reflux disease (GERD) and relieve its symptoms such as:
- the burning feeling that rises from the chest to the throat (heartburn).
- the flow of bitter/sour juice into the mouth (regurgitation).
- treat symptoms of non-erosive reflux disease (NERD) such as heartburn and regurgitation.
- maintain longer term healing of gastroesophageal reflux disease (GERD).
- treat rare conditions where excess acid is produced in the stomach (e.g., Zollinger-Ellison syndrome).
treat ulcers caused by infection with the bacterium, Helicobacter pylori (H. pylori), and prevent these ulcers from coming back by:
- taking pms-RABEPRAZOLE EC with antibiotics such as amoxicillin and clarithromycin, as directed by your doctor.
- following the information on the antibiotics provided to you by the pharmacist.
How does pms-RABEPRAZOLE EC work?
pms-RABEPRAZOLE EC is a medicine called a proton pump inhibitor (PPI). pms-RABEPRAZOLE EC works by reducing the amount of acid made in your stomach.
What are the ingredients in pms-RABEPRAZOLE EC?
Medicinal ingredients: rabeprazole sodium
Non-medicinal ingredients:
10 mg Tablets: Antifoam, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide Black, Iron Oxide Red, Lecithin, Magnesium Oxide, Magnesium Stearate, Mannitol, Methacrylic Acid Copolymer, Polyethylene Glycol, Shellac Glaze, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate and Zein.
20 mg Tablets: Ammonium Hydroxide, FD&C Red No. 40 Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Magnesium Oxide, Magnesium Stearate, Mannitol, Methacrylic Acid Copolymer, Polyethylene Glycol, Propylene Glycol, Shellac Glaze, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Iron Oxide and Zein.
pms-RABEPRAZOLE EC comes in the following dosage forms:
Tablets of 10 mg and 20 mg
Do not use pms-RABEPRAZOLE EC if:
you are allergic to:
- rabeprazole or other medications in this class
- the “non-medicinal” ingredients in pms-RABEPRAZOLE EC tablets (see What are the ingredients in pms-RABEPRAZOLE EC?)
- you are taking rilpivirine
- you are unable to take amoxicillin or clarithromycin if you are using pms-RABEPRAZOLE EC to treat ulcers caused by an infection (H. pylori)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-RABEPRAZOLE EC. Talk about any health conditions or problems you may have, including if you:
- have any liver problems
- experience symptoms including palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, muscle weakness, cramps and convulsions. These may be signs of low magnesium levels in your blood
- are taking methotrexate
are pregnant or planning to become pregnant
- are breast-feeding or planning to breast-feed
- are due to have a specific blood test (Chromogranin A)
Other warnings you should know about:
Long-term use of pms-RABEPRAZOLE EC may prevent normal absorption of vitamin B12 from the diet and could lead to vitamin B12 deficiency. Talk to your doctor.
Using pms-RABEPRAZOLE EC for a long period of time (a year or longer) may increase the risk of fractures of the hip, wrist or spine. Talk to your doctor about your risk.
Using medicines like pms-RABEPRAZOLE EC for a long period of time may cause a growth in your stomach (polyp). This can lead to intestinal blockage or bleeding. Talk to your doctor if you experience nausea or stomach pain while you are taking pms-RABEPRAZOLE EC.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with pms-RABEPRAZOLE EC:
- ketoconazole
- digoxin
- warfarin
- antiretroviral drugs such as atazanavir, nelfinavir, saquinavir
- methotrexate
How to take pms-RABEPRAZOLE EC:
- Take pms-RABEPRAZOLE EC exactly as prescribed by your doctor, usually for a specific number of weeks.
- Use the lowest dose and shortest time as determined by your doctor.
- Do not stop taking pms-RABEPRAZOLE EC even when you start to feel better. If you stop taking pms-RABEPRAZOLE EC too soon, your symptoms may return.
- Take pms-RABEPRAZOLE EC with or without meals.
- Swallow tablets whole with a liquid. Do not chew or crush the tablets.
- Talk to your doctor if you have any concerns.
Usual dose:
| Condition | Adult Dose | How often | How long |
|---|---|---|---|
| reflux symptoms with esophagitis | 20 mg | once daily | four weeks |
| reflux symptoms without esophagitis, such as heartburn and regurgitation | 10 mg to a maximum of 20 mg | once daily | four weeks |
| duodenal ulcer | 20 mg | once daily | up to four weeks |
| stomach ulcer | 20 mg | once daily | up to six weeks |
| ulcer caused by H. pylori infection1 | 20 mg | twice daily in combination with antibiotic drugs (500 mg clarithromycin and 1000 mg amoxicillin) preferably with the morning and evening meals | one week |
- 1. If you are given pms-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:
If you think you, or a person you are caring for, have taken too much pms-RABEPRAZOLE EC, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take one dose of pms-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.
What are possible side effects from using pms-RABEPRAZOLE EC?
Like all medicines, pms-RABEPRAZOLE EC can cause side effects.
Headache and diarrhea are the most common side effects experienced with pms-RABEPRAZOLE EC. Less common side effects are rash, itchiness and dizziness. If any of these become troublesome, consult your doctor.
If you experience symptoms of low magnesium levels in your body, your doctor may stop pms-RABEPRAZOLE EC. Tell your doctor right away if you have any of these symptoms:
- seizures.
- dizziness.
- abnormal or fast heartbeat.
- jitteriness.
- jerking movements or shaking (tremors).
- muscle weakness.
- spasms of the hands and feet.
- cramps or muscle aches.
- spasm of the voice box.
- fracture (broken bone).
- Blood in stool.
Stopping your PPI therapy after taking it for a long time, may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when discontinuing your PPI therapy.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Subacute cutaneous lupus erythematosus (SCLE). New or worsening joint pain and rash that gets worse in the sun | ✓ | ||
| Severe diarrhea accompanied with blood and/or mucous | ✓ | ||
| Clostridium difficile colitis (Bowel inflammation): Symptoms include severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness | ✓ | ||
| Clostridium difficile colitis (Bowel inflammation): If you are currently taking or have recently taken antibiotics and you develop diarrhea, contact your doctor, even if the diarrhea is relatively mild. | ✓ | ||
Microscopic colitis (inflammation of the gut):
The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
|---|
Storage:
Store at room temperature (15°C to 30°C) and protect from moisture.
Keep out of reach and sight of children.
If you want more information about pms-RABEPRAZOLE EC:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1- 888-550-6060.