Ranitidine (Sorres Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RANITIDINE is used to treat and prevent ulcers in the stomach and intestines. Ranitidine is also used to treat conditions in which the stomach produces too much acid and conditions in which acid comes up into the esophagus and causes heartburn, such as gastroesophageal reflux disease (GERD).

What it does:

RANITIDINE is in a class of drugs called histamine receptor antagonists. Ranitidine works by decreasing the amount of acid the stomach produces.

When it should not be used:

Ranitidine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take ranitidine without first talking to your doctor if you are pregnant.

Ranitidine passes into breast milk. Do not take ranitidine without first talking to your doctor if you are breast-feeding a baby.

What the medicinal ingredient is:

Ranitidine hydrochloride

What the important nonmedicinal ingredients are: colloidal silicon dioxide, croscarmellose sodium, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part. Hydrolysed, talc, titanium dioxide and xanthan gum.

What dosage forms it comes in:

Tablets: 150 mg and 300 mg

WARNINGS AND PRECAUTIONS

Before taking this medication, tell your doctor if you have

• Kidney disease;
• Liver disease; or
• Porphyria

You may not be able to take ranitidine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

There are no restrictions on food, beverages, or activity while taking ranitidine, unless otherwise directed by your doctor.

INTERACTIONS WITH THIS MEDICATION

Do not take antacids within 1 hour of taking ranitidine. Antacids may decrease the effectiveness of ranitidine.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• triazolam (Halcion); or
• the anticoagulant (blood thinner) such as warfarin (Coumadin).

You may not be able to take RANITIDINE, or you may require a dosage adjustment or special monitoring during treatment if you are taking either of the medicines listed above.

Ranitidine may affect the actions of other medications by changing the acidity of the stomach. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines during treatment with RANITIDINE.

PROPER USE OF THIS MEDICATION

Usual dose:

Take RANITIDINE exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Do not stop taking ranitidine without first talking to your doctor. It may take up to 8 weeks for an ulcer to heal.

Page 25 of 25 Overdose:

Seek emergency medical attention.

Symptoms of a ranitidine overdose include nausea, vomiting, diarrhea, increased saliva production, difficulty breathing, and a fast heartbeat.

Missed Dose:

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If you experience any of the following serious side effects, stop taking ranitidine and call your doctor immediately or seek emergency medical treatment:

• an allergic reaction (difficulty breathing; closing

  of your throat; swelling of your lips, tongue, or face; or hives);

• easy or unusual bruising or bleeding;
• bleeding gums;
• irregular heartbeat; or
• yellowing of the skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take RANITIDINE and talk to your doctor if you experience:

• dizziness;
• headache; or
• diarrhea, nausea, or constipation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

HOW TO STORE IT

Store RANITIDINE at room temperature, between 15°C and 30°C. Protect from light.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by post to: Sorres Pharma Inc., 6111 Royalmount Ave. Montreal QC H4P 2T4

Last revised: April 1, 2010.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reactions to this drug you may notify Health Canada by:

Toll-free telephone: 866-234-2345

Toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness

Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.