Details for: RAN-PANTOPRAZOLE
Company: RANBAXY PHARMACEUTICALS CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02305046 | RAN-PANTOPRAZOLE | PANTOPRAZOLE (PANTOPRAZOLE SODIUM) | 40 MG | TABLET (DELAYED-RELEASE) | ORAL |
Summary Reports
Summary Safety Review - Proton Pump Inhibitors (PPIs) - Assessing the risk of a type of skin reaction [Subacute Cutaneous Lupus Erythematosus (SCLE)]
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
RAN-PANTOPRAZOLE is used to treat stomach acid related problems. This includes:
- Stomach ulcer.
A stomach ulcer is a sore on the lining of the stomach. This is also known as a gastric ulcer. - Duodenal ulcer.
A sore on the lining of the duodenum. The duodenum is the first part of the small intestine. - Duodenal ulcer caused by the bacteria Helicobacter pylori (H. pylori).
PANTOPRAZOLE is used in combination with two antibiotics. - Reflux esophagitis.
This is a severe form of heartburn. - Symptoms of gastro-esophageal reflux disease (GERD).
The symptoms include heartburn and acid regurgitation. GERD is a condition in which stomach acid backs up into your esophagus. - When taking Non-steroidal anti-inflammatory drugs (NSAIDs).
Stops stomach and duodenal ulcers from forming.
What it does
RAN-PANTOPRAZOLE is a proton pump inhibitor. It reduces the amount of acid your stomach makes.
When it should not be used
- You are allergic to any of its ingredients. (See What are the ingredients in RAN-PANTOPRAZOLE?).
- You are taking rilpivirine
What the medicinal ingredient is
pantoprazole sodium.
What the non-medicinal ingredients are
Calcium stearate, colloidal silicon dioxide, crospovidone, mannitol, hydroxypropylmethyl cellulose, polyethylene glycol, sodium carbonate anhydrous, sodium starch glycollate, sodium hydroxide, Eudragit (contains: methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate and polysorbate) and opadry yellow (contains: lecithin (soy), titanium dioxide, yellow iron oxide, polyvinyl alcohol, talc and xanthan gum).
What dosage form it comes in
- Tablet, 20 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RAN-PANTOPRAZOLE. Talk about any health conditions or problems you may have, including if you:
- are taking other medications (see The following may interact with RAN-PANTOPRAZOLE).
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breast feed. Pantoprazole has been found in human breast milk. Talk with your doctor.
- suffer these effects:
- unexplained weight loss.
- severe or persistent diarrhea.
- repeated vomiting.
- vomiting blood.
- dark stools.
- tiredness (anemia).
- difficulty in swallowing.
- Have a history of liver problems.
- have low magnesium in the body, which may cause symptoms such as:
- rapid heartbeat.
- dizziness, seizures.
- muscle cramping, twitches or spasms.
- are due to have a specific blood test (Chromogranin A)
Other warnings you should know about:
You should take RAN-PANTOPRAZOLE exactly as prescribed. You will use the lowest dose and shortest time
suitable for your condition. Talk to you doctor if you have any concerns about your treatment.
Depending on your condition, your doctor may tell you to use this type of medicine (proton pump inhibitors) for a
longer period.
Using proton pump inhibitors for a long time (every day for a year or longer) may increase risks of broken bones of
the hip, wrist or spine. Talk to your doctor about this risk.
Long term use of proton pump inhibitors may interfere with the absorption of Vitamin B12 from the diet. This may
cause a shortage of Vitamin B12 in your body. Talk to your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals,
natural supplements or alternative medicines.
Interactions with this medication
Warfarin, atazanavir, nelfinavir, saquinavir/ritonavir, methotrexate.
Proper use of this medication
- Take RAN-PANTOPRAZOLE in the morning.
- with or without food.
- Swallow the tablet(s) whole with water.
- Do not crush or chew the tablet(s).
Usual adult dose
Your doctor will have told you what dose to take for your condition. Follow your doctor’s directions carefully as they
may be different from the information provided in this leaflet.
RAN-PANTOPRAZOLE may be used in combination with two antibiotics to treat ulcers caused by H. pylori. RAN-PANTOPRAZOLE
and both antibiotics are to be taken twice a day, or as prescribed by your doctor.
Overdose
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at your regular time. Do not double doses.
Side effects and what to do about them
Like all medicines, RAN-PANTOPRAZOLE may cause side effects. Side effects have generally been mild and did not last a long time. These are not all the possible side effects you may feel when taking RAN-PANTOPRAZOLE.
The most common side effects are:
- headache.
- diarrhea.
- nausea.
Your symptoms may get worse after stopping your medication. This may occur as your stomach may increase the production of acid.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| RARE. | |||
| Disturbances in vision. Most cases reported are not serious. |
✔ | ||
| ISOLATED CASES. | |||
| Liver damage. Symptoms include a yellow tinge to the skin and eyes. | ✔ | ||
| Serious skin reactions. Symptoms include widespread rash, itching, or hives. Peeling of the skin, blisters on the skin, mouth, nose, eyes and genitals are other symptoms. | ✔ | ||
| Muscle wasting. | ✔ | ||
| Clostridium difficile colitis (bowel inflammation). Symptoms include severe (watery or bloody) diarrhea, fever, and abdominal pain or tenderness. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store RAN-PANTOPRAZOLE at room temperature, (15°C to 30°C).
Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected
side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html);
- By calling 1-866-234-2345 (toll-free);
- By Completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels, and the consumer side effect Reporting Form are available at MedEffect at (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html).
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
More information
- 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-866-840-1340.
This leaflet was prepared by Ranbaxy Pharmaceuticals Canada Inc.
Last Revised: January 9, 2018
All trademarks are the property of their respective owners.