Consumer Information for: MAR-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

MAR-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 MAR-RANITIDINE (ranitidine hydrochloride) tablets if you are allergic (hypersensitive) to ranitidine or any other ingredients in MAR-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

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

Warnings and precautions

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

  • have stomach cancer
  • you have kidney disease, your doctor may lower your dose of Mar-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 MAR-RANITIDINE works, or make it more likely that you’ll have side effects. MARRANITIDINE can also affect how some other medicines work.

Drugs that may interact with MAR-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 MAR-RANITIDINE administration.
Proper use of this medication

Usual Dose

Always take MAR-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 MAR-RANITIDINE, contact your doctor or pharmacist for advice. If possible, show them the MAR-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 and what to do about them
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
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 MARRANITIDINE, 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 MARRANITIDINE 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:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

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, Marcan Pharmaceuticals Inc., at: 1-613-228-2600

Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit 4
Ottawa, ON K2E 7Z7

This leaflet was prepared by Marcan Pharmaceuticals Inc.

Date of Preparation: April 25, 2016

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