Consumer Information for: RAN-RANITIDINE

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 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

RAN-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 RAN-RANITIDINE if you are allergic (hypersensitive) to ranitidine or any other ingredients of RAN-RANITIDINE (see What the nonmedicinal ingredients are).

What the medicinal ingredient is

ranitidine hydrochloride

What the non-medicinal ingredients are

RAN-RANITIDINE 150 mg Tablets

The non-medicinal ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The film-coating suspension contains the following excipients: hydroxypropyl cellulose, hypromellose, and titanium dioxide.

RAN-RANITIDINE 300 mg Tablets

The non-medicinal ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The film-coating suspension contains the following excipients: hydroxypropyl cellulose, hypromellose, and titanium dioxide.

What dosage form it comes in

Each tablet contains either 150 mg or 300 mg ranitidine (as ranitidine hydrochloride).

Warnings and precautions

BEFORE you use RAN-RANITIDINE talk to your doctor or pharmacist if you:

have stomach cancer
have kidney disease, your doctor may lower your dose of RAN-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).

Under rare circumstances supervised by the doctor, H₂- receptor antagonists such as RAN-RANITIDINE 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'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 RAN-RANITIDINE works, or make it more likely that you’ll have side effects. RAN-RANITIDINE can also affect how some other medicines work.

Drugs that may interact with RAN-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). Your doctor may advise that you take high doses or oral sucralfate (e.g. 2g) at least 2 hours after RAN-RANITIDINE administration.

Proper use of this medication

Usual Adult Dose

Always take RAN-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 RAN-RANITIDINE, contact your doctor or pharmacist for advice. If possible, show them the RAN-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
Symptom / effect	Talk with your doctor or pharmacist only if severe	Talk with your doctor or pharmacist in all cases	Stop taking drug and seek immediate emergency medical attention
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 RAN-RANITIDINE, contact your doctor or pharmacist.

How to store

Store RAN-RANITIDINE tablets between 15° C and 25° C. Protect from light and moisture. 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 www.healthcanada.gc.ca/medeffect
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 0701E
  Ottawa ON K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect^TM 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 found by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1-866-840-1340

RANBAXY
This leaflet was prepared by:
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5

Last revised: March 31, 2015

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