Patient Medication Information: uses, side effects, how to take - PMS-Nizatidine

What is pms-NIZATIDINE used for?

pms-NIZATIDINE is used to treat stomach acid related problems. This includes:

Healing and pain relief of ulcers (sores) on the lining of the duodenum. The duodenum is the first part of the small intestine.
Healing and pain relief of sores on the lining of the stomach.
Healing and pain relief caused by gastro-esophageal reflux disease (GERD). This is a condition where stomach acid backs up into your esophagus (gullet). This can cause pain or discomfort known as indigestion, acid reflux or heartburn.
Preventing sores on the lining of the duodenum from coming back.

How does pms-NIZATIDINE work?

pms-NIZATIDINE belongs to a group of medicines called H₂-receptor antagonists (anti-ulcer medicines). It works by reducing the amount of acid in your stomach.

What are the ingredients in pms-NIZATIDINE?

Medicinal ingredients: Nizatidine

Non-medicinal ingredients:

150 mg capsules: Corn starch, magnesium stearate, pregelatinized starch and silicon fluid.

The printed capsule shells also contain benzyl alcohol, butylparaben, calcium disodium edetate, carboxy-methylcellulose sodium, gelatin, iron oxide black, iron oxide yellow, methylparaben, potassium hydroxide, propylparaben, shellac, sodium lauryl sulfate, sodium propionate and titanium dioxide.

300 mg capsules: Corn starch, carboxymethylcellulose sodium, pregelatinized starch, povidone, silicon fluid and talc.

The printed capsule shells also contain benzyl alcohol, butylparaben, calcium disodium edetate, gelatin, iron oxide black, iron oxide red, iron oxide yellow, methylparaben, potassium

hydroxide, propylparaben, shellac, sodium lauryl sulfate, sodium propionate and titanium dioxide.

pms-NIZATIDINE comes in the following dosage forms:

Capsules 150 mg and 300 mg

Do not use pms-NIZATIDINE if:

you are allergic to nizatidine or to any of the other ingredients in pms-NIZATIDINE. (See “What are the ingredients in pms-NIZATIDINE?”).
you are allergic to any drug in the group of medicines called H₂-receptor antagonists

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-NIZATIDINE. Talk about any health conditions or problems you may have, including if you:

have kidney problems.
have liver problems.
are pregnant or plan to become pregnant.
are breast-feeding or plan to breast-feed. pms-NIZATIDINE passes in breast milk.

Other warnings you should know about:

Long-term use of pms-NIZATIDINE may lead to Vitamin B12 deficiency.
pms-NIZATIDINE can cause abnormal urine test results (false-positive results) for a liver compound called urobilinogen.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with pms-NIZATIDINE:

Aspirin: Acetylsalicylic Acid (ASA), used to treat pain and fever

How to take pms-NIZATIDINE:

Use pms-NIZATIDINE exactly as directed by your healthcare professional.
Take pms-NIZATIDINE with a full glass of water.
Antacids may be used together with pms-NIZATIDINE if needed.
Do not share your medicine.

Usual dose:

Adults

For stomach or duodenal ulcers: One 300 mg capsule or two 150 mg capsules once daily at bedtime. Alternatively, 150 mg twice daily may be used. Healing occurs within 4 weeks in most cases of duodenal ulcer. If your ulcer has not fully healed after 4 weeks, your doctor may treat you for a further 4 weeks.
Maintenance therapy in duodenal ulcer: One 150 mg capsule once daily at bedtime for 6 - 12 months depending on the severity of the condition.
Gastroesophageal Reflux Disease: One 150 mg capsule twice daily for the treatment of indigestion, acid reflux and heartburn.

Overdose:

If you think you, or a person you are caring for, have taken too much pms-NIZATIDINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What are possible side effects from using pms-NIZATIDINE?

These are not all the possible side effects you may have when taking pms-NIZATIDINE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

sweating
sleepiness
headache
stomach pain
feeling weak or tired
pain in your whole body
back pain
chest pain
diarrhea
vomiting
passing gas more than usual
constipation
indigestion
nausea (feeling sick)
heartburn
insomnia (difficulty falling asleep)
feeling anxious or nervous
runny or stuffed nose
sore throat
increased coughing
dizziness
hives (urticaria)
rash
fever
lazy eye
unusual tiredness, shortness of breath when exercising
flaking or peeling of the skin
joint pain, aching muscles, muscle tenderness or weakness not caused by exercise
if you are a man, breast enlargement or an inability to get or maintain an erection
confusion

Serious side effects and what to do about them

Symptom / effect		Talk to your healthcare professional			Stop taking drug and
	Only if severe		In all cases		get immediate
					medical help
RARE
Allergic Reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat.				✓
Liver Disorder: yellowing of the skin or eyes, dark urine and pale stools, abdominal pain, nausea, vomiting, itching			✓
Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness			✓
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness			✓
Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing.			✓
Vasculitis (narrowing or blockage of the blood vessels): general feeling of being unwell, fever, tiredness, weight loss			✓
Frequent infections such as fever, severe chills, sore throat or mouth ulcers			✓
Hyperuricemia (high uric acid levels in the blood): severe pain and swelling in the joints, kidney stones				✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

Storage:

Store at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

If you want more information about pms-NIZATIDINE:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.
Pharmascience Inc.
Montréal, Québec
H4P 2T4.

PMS-Nizatidine: Uses, Side Effects and Dosage