Consumer Information for: JAMP-RANITIDINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for
  • to heal ulcers in the stomach, or the part that it empties into (the duodenum).
  • to prevent stomach ulcers which may be caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs), often used to treat arthritis
  • to prevent ulcers from bleeding
  • to heal or stop problems caused by acid in the food pipe (esophagus) or too much acid into the stomach. This can cause pain or discomfort sometimes known as indigestion or heartburn
  • to stop acid coming up from the stomach while under anaesthetic during an operation
What it does

JAMP-RANITIDINE belongs to a group of medicines called H2-receptor blockers. It works by reducing the amount of acid in your stomach.

When it should not be used

Don’t take JAMP-RANITIDINE (ranitidine hydrochloride) tablets if you are allergic (hypersensitive) to ranitidine or any other ingredients in JAMP-RANITIDINE(see What the nonmedicinal ingredients are).

What the medicinal ingredient is

Ranitidine hydrochloride

What the non-medicinal ingredients are

Castor oil, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.

What dosage form it comes in

JAMP-RANITIDINE is available as tablets, 150 mg and 300 mg

Warnings and precautions

Before you use JAMP-RANITIDINE talk to your doctor or pharmacist if:

  • have stomach cancer
  • you have kidney disease, your doctor may lower your dose of Jamp-Ranitidine
  • have a rare condition called acute porphyria (a blood disease)
  • have lung disease
  • are diabetic
  • have any problems with immune system
  • have had stomach ulcers before and you are taking non-steroidal anti-inflammatory drugs (NSAIDs)
  • are taking any other medications including NSAIDs (See Interactions with this Medication)

Under rare circumstances supervised by the doctor, H2 receptor antagonists such as ranitidine hydrochloride might be used for long periods. Long term use of H2 receptor antagonists may prevent normal absorption of vitamin B12 from the diet and could lead to vitamin B12 deficiency. Talk to your doctor.

Interactions with this medication

Tell your doctor or pharmacist if you are taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes medicines bought without a prescription. Some medicines can affect how JAMP-RANITIDINE works, or make it more likely that you’ll have side effects. JAMP-RANITIDINE can also affect how some other medicines work.

Drugs that may interact with JAMP-RANITIDINE include:

  • Procainamide or N-acetylprocainamide
  • (used to treat heart problems)
  • warfarin (used to thin the blood)
  • Triazolam (used to treat insomnia)
  • Midazolam(a sedative that may be given just before an operation)
  • Ketoconazole (used to treat fungal infections)
  • Atazanavir Delaviridine (used to treat HIV)
  • Gefitnib (used to treat lung cancer)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and inflammation)
  • Sucralfate (used to treat ulcers). Your doctor may advise that you take high doses or oral sucralfate (e.g. 2g) at least 2 hours after JAMP-RANITIDINE administration.
Proper use of this medication

Usual Adult dose

Always take JAMP-RANITIDINE exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

The usual dose is either:

  • 150 mg in the morning and 150 mg in the evening or,
  • 300 mg at bedtime

  • Your exact dose will depend on your particular stomach condition. Your doctor will tell you the dose you should take.

    Swallow each tablet whole with some water.

Overdose

If you take too much JAMP-RANITIDINE, contact your doctor or pharmacist for advice. If possible, show them the JAMP-RANITIDINE pack.

In the event of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

Side effects may include:

  • allergic reactions
  • skin rash
  • inflammation of blood vessels (vasculitis)
  • inflammation of the pancreas (pancreatitis)
  • inflammation of the liver (hepatitis), sometimes with yellowing of the eyes or skin (jaundice)
  • inflammation of the kidney (interstitial nephritis)
  • slow, fast or irregular heartbeat
  • diarrhea, constipation, nausea, vomiting, stomach pain
  • feeling confused, depressed, or excited, or seeing, or hearing things that are not really there (hallucinations), trouble sleeping (insomnia); feeling sleepy (somnolence)
  • joint or muscle pain, malaise, uncontrolled movement
  • headache, dizziness, blurred vision
  • unusual hair loss or thinning (alopecia)
  • unable to get or maintain an erection (impotence)
  • unusal secretion of breast milk or breast enlargement in men

If you have any concerns about side effects, tell your doctor, nurse or pharmacist.

Side effects that may show up in blood tests:

  • change to liver function
  • low levels of white blood cells
  • decrease in number of blood platelets (cells that help blood to clot)
  • decrease in number of all types of blood cells
  • small increase in the level of creatinine (a waste product) in your blood.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Rare
Hypersensitivity Reaction raised and itchy rash (hives), swelling sometimes of the face or mouth (angioedema), chest pain, shortness of breath, unexplained fever, wheezing, or difficulty in breathing, feeling faint, especially, when standing up, collapse    
Very rare
Serious skin Reactions Skin rash, which may blister, and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge)    
Hepatitis Yellowing of the skin or whites of the eyes, dark or tea coloured urine, pale coloured stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on right side below the ribs    
Cardiovascular Slow, fast or irregular heartbeat    
This is not a complete list of side effects. For any unexpected effects while taking JAMP-RANITIDINE, contact your doctor or pharmacist.
How to store

Store between 15°C and 30°C. Protect from light and moisture. Do not store in the bathroom. Keep JAMP-RANITIDINE out of the reach 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 (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free)
  • By completing a Consumer Side Effects Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada,
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). .

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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, JAMP Pharma Corporation at: 1-866-399-9091

JAMP Pharma Corporation, 1310 rue Nobel, Boucherville, Québec, J4B 5H3

This leaflet was prepared by JAMP Pharma Corporation

Date of Preparation: May 5, 2017