Apo-Ranitidine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-RANITIDINE is a brand name for the drug ranitidine hydrochloride. APO-RANITIDINE is used to treat stomach or intestinal ulcers and prevent their return. It can relieve discomfort from ulcer pain and the heartburn associated with acid reflux.

What it does:

APO-RANITIDINE belongs to a group of medicines called H₂-receptor site antagonists. It acts by blocking histamine receptors that are present on the cells in the stomach lining thereby reducing the amount of acid produced by these cells.

When it should not be used:

Do not take APO-RANITIDINE if you have previously had an allergic reaction to the medicine or any of the non-medicinal ingredients of the product. APO-RANITIDINE should not be used if you have a history of acute porphyria.

What the medicinal ingredient is:

Ranitidine Hydrochloride

What the non-medicinal ingredients are:

Butylparaben, hypromellose, peppermint oil, potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, sodium phosphate dibasic, sorbitol solution.

What dosage forms it comes in:

APO-RANITIDINE is available as an oral solution, 15 mg/mL (300 mL).

WARNINGS AND PRECAUTIONS

• This medicine can mask the symptoms of stomach cancer and therefore delay the diagnosis of this condition. For this reason, the possibility of

  • stomach cancer should be excluded by your doctor before starting to use this medicine.
  • If you have severe decreased renal function, the dosage of ranitidine should be reduced as advised by your doctor.

  • Use in Pregnancy: This medicine is not recommended for use during pregnancy unless considered necessary by your doctor. The potential benefits must be weighed against possible hazards to you and your baby

  • Use in Nursing Mothers: This medicine is secreted into breast milk. It should not be used during breast-feeding unless considered essential by your doctor.

  • Use in Children (< 18 years of age): Experience with this medicine in children is limited. It has, however, been used successfully in children aged 8 to 18 years in oral doses up to 150 mg twice daily when used for short periods of time.

  • Use in the Elderly (>65 years of age): If you are older than 65 years of age make sure that your doctor has ruled out the possibility of stomach cancer before starting this medicine. Also, make sure your doctor knows if you are taking non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin). Tell your doctor if you experience confusion and depression.
  • This medicine should not be used if you have acute porphyria, a lifelong inherited blood disease characterized by sudden attacks of high blood pressure, mental disturbances and abdominal pain.

INTERACTIONS WITH THIS MEDICATION

APO-RANITIDINE interacts with other drugs, including:

• Non-steroidal anti-inflammatory
• Ketoconazole
• Hypoglycemic drugs
• Theophylline
• Sucralfate

You should check with your doctor or pharmacist before taking any 'over-the-counter' medicine or have concerns regarding drug interactions.

PROPER USE OF THIS MEDICATION

Usual dose:

Never take more than the prescribed dose. Discuss with your doctor or pharmacist for proper use of this medicine.

Elderly patients should start at the lowest recommended dose and be adjusted as necessary.

Missed Dose:

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

If you are still unsure, check with your doctor or pharmacist.

Overdose:

If you take more than the prescribed dose please consult your physician or Emergency room as soon as possible.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, APO-RANITIDINE can cause some side effects. These side effects are most likely to be minor and temporary.

Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects are experienced, do not hesitate to report them to your doctor.

• Headache, sometimes severe; malaise; dizziness; somnolence; insomnia; vertigo; and reversible blurred vision. Isolated cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. In addition, reversible involuntary movement disorders have been reported rarely.
• Isolated reports of changes to heart rate (increase & decrease) and rhythm have been noted.
• Constipation, diarrhea, nausea/vomiting and abdominal discomfort/pain.
• Occasional reports of abnormal liver function and hepatitis with or without jaundice have been noted. Stop taking ranitidine immediately. These are usually reversible, but in exceedingly rare circumstances, death has occurred.
• Pain in the muscles and joints

• Change in results of liver function tests.

  • Swelling of breasts or breast soreness in females and males.
  • Rash, rare cases of inflammation near the skin or slight hair loss from the skin.
  • Rare cases of allergic reactions (including chest pain, coughing, fever, rash, swelling, hives, low blood pressure) and small increases in serum creatinine have occasionally occurred after a single dose. Rare cases of acute pancreatitis and reversible impotence have been reported.

This is not a complete list of side effects. For any unexpected effects while taking APO-RANITIDINE, contact your doctor or pharmacist immediately

HOW TO STORE IT

Store between 15ºC and 30ºC. Protect from light. Keep all medicines out of the reach of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about APO-RANITIDINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667-4708

Last revised: April 30, 2019