Patient Medication Information: uses, side effects, how to take - Ranitidine (Cobalt Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
RANITIDINE (ranitidine hydrochloride) tablets are used in the treatment of:
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 in 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:
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 RANITIDINE tablets if you are allergic (hypersensitive) to ranitidine or any other ingredients of RANITIDINE (see What the nonmedicinal ingredients are). What the medicinal ingredient is:
Ranitidine hydrochloride
What the nonmedicinal ingredients are:
Croscarmallose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, and triethyl citrate.
What dosage forms it comes in:
RANITIDINE is available as tablets, 150 mg and 300 mg.
WARNINGS AND PRECAUTIONS
BEFORE you use RANITIDINE talk to your doctor or pharmacist if you:
- have stomach cancer
have kidney disease, your doctor may lower your dose of
RANITIDINE
have a rare condition called acute porphyria (a blood
disease)
- have lung disease
- are diabetic
- have any problems with your immune system
have had stomach ulcers before and you are taking Non-
Steroidal Anti-Inflammatory (NSAID) medicines
are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed
are taking any other medications including NSAIDs (see
Interactions with this Medication).
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you‘re 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 RANITIDINE works, or make it more likely that you’ll have side effects. RANITIDINE can also affect how some other medicines work.
Drugs that may interact with 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 or delaviridine (used to treat HIV)
- gefitnib (used to treat lung cancer)
Non-Steroidal Anti-Inflammatory (NSAID) medicines
(used to treat pain and inflammation)
- sucralfate (used to treat ulcers)
PROPER USE OF THIS MEDICATION
Usual Adult Dose:
Always take RANITIDINE exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re 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 RANITIDINE, contact your doctor or pharmacist for advice. If possible, show them the RANITIDINE pack.
In case of drug 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 whites of the eyes or skin (jaundice)
- inflammation in 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) unusual secretion of breast milk or breast enlargement in men If you have any concerns about the side effects, tell your doctor, nurse or pharmacist.
Side effects that may show up in your blood tests:
- changes 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 | ||||
| Symptoms / effects | Talk with your physician or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| 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, | ✓ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptoms / effects | Talk with your physician or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| 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 RANITIDINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15°C and 30°C. Protect from light and moisture. Do not store in the bathroom. Keep RANITIDINE out of the reach of children.
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:
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- 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 0701E 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
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111