Patient Medication Information: uses, side effects, how to take - PRZ-Metoclopramide
What is PRZ-METOCLOPRAMIDE used for?
PRZ-METOCLOPRAMIDE is used along with other treatments:
- To manage slowed stomach emptying seen in people with gastritis and in those recovering from certain types of gastric tests or surgery.
- To help in bowel intubation procedures.
- To help in barium examinations of the stomach and other medical tests in patients with problems in their gastrointestinal tract (digestive system).
- To reduce vomiting that may occur after certain types of surgery.
How does PRZ-METOCLOPRAMIDE work?
PRZ-METOCLOPRAMIDE stimulates the muscles of the gastrointestinal tract. This helps speed the movement of food through the stomach and intestines.
What are the ingredients in PRZ-METOCLOPRAMIDE? Medicinal ingredients: metoclopramide hydrochloride Non-medicinal ingredients:
Tablets: Colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose,
Serious Warnings and Precautions
TARDIVE DYSKINESIA
- Treatment with metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that may become permanent. You are more likely to get TD if you take PRZ-METOCLOPRAMIDE at higher doses or for longer.
- There is no known treatment for TD. Stop taking PRZ-METOCLOPRAMIDE and get immediate medical help if you get any symptoms of TD. These include: muscle twitching or unusual / abnormal movement of the face or tongue or other parts of your body.
- Treatment with PRZ-METOCLOPRAMIDE for longer than 12 weeks should be avoided. Your healthcare professional will decide if you can take PRZ-METOCLOPRAMIDE for longer than 12 weeks.
polacrilin potassium resin.
PRZ-METOCLOPRAMIDE comes in the following dosage forms:
Tablets: 5 mg and 10 mg
Do not use PRZ-METOCLOPRAMIDE if:
- You are allergic to metoclopramide hydrochloride or to any of the other ingredients in PRZ-METOCLOPRAMIDE.
- You have had tardive dyskinesia in the past.
- You experienced a movement disorder after treatment with metoclopramide.
- Whenever stimulation of gastrointestinal muscles might be dangerous, such as when there is gastrointestinal bleeding or other abnormal condition in your digestive system.
- You have a tumour in the adrenal gland.
- You have epilepsy.
- You are receiving other drugs which can produce side effects such as an inability to sit still, muscle contraction, tremors, stiff muscles, and facial movements (extrapyramidal reactions).
PRZ-METOCLOPRAMIDE should not be used in children less than one year of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PRZ-METOCLOPRAMIDE. Talk about any health conditions or problems you may have, including if you:
- have a history of bleeding (hemorrhage), a blockage (obstruction), or a tear (perforation) in your stomach or intestines
- have a history of seizures such as in epilepsy
- have Parkinson’s disease
- have or have had breast cancer
- have liver, kidney, or heart problems
- have diabetes
- have or have had depression
- are over the age of 65 (you may need a reduced dosage)
Other warnings you should know about:
Tardive dyskinesia:
PRZ-METOCLOPRAMIDE can cause a condition called tardive dyskinesia. This is more likely to happen in patients who take PRZ-METOCLOPRAMIDE for longer than 12 weeks and in those taking a higher dose. You should not take it for longer than 12 weeks unless your doctor has told you to. However, it can also happen soon after starting PRZ-METOCLOPRAMIDE. Tardive dyskinesia happens more in elderly patients, especially women and in patients with diabetes mellitus. Stop taking PRZ-METOCLOPRAMIDE and get immediate medical help if you get any of the following symptoms of tardive dyskinesia: muscle twitching or unusual / abnormal movement of the face or tongue or other parts of your body. There is no known treatment for tardive dyskinesia. However, it may go away partly or completely after stopping treatment with PRZ-METOCLOPRAMIDE.
Pregnancy:
Tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. It is not known if PRZ-METOCLOPRAMIDE is safe in pregnancy. You should not take PRZ-METOCLOPRAMIDE if you are pregnant unless your healthcare professional advises that you can.
Breastfeeding:
Tell your healthcare professional if you are breastfeeding or plan to breastfeed. PRZ- METOCLOPRAMIDE can pass into your breastmilk and harm your baby. Your healthcare professional will tell you if you can breastfeed your baby while taking PRZ-METOCLOPRAMIDE. If you do breastfeed while taking PRZ-METOCLOPRAMIDE, talk to your healthcare professional for how to monitor your baby for side effects.
Use in Children:
Metoclopramide must not be used in children under 1 year of age. Metoclopramide should not be used in children over 1 year of age unless the doctor believes the benefit outweighs the risk. Shaking, tremor, stiffness and involuntary movement may occur in children. If you observe these reactions in your child, contact your healthcare professional immediately. Children's dosage must not exceed
0.5 mg / kg / day.
Metoclopramide may cause side effects such as an inability to sit still, muscle contraction, tremors, stiff muscles, and unusual movements of the face. These effects are more common in children than in adults. Infants treated with metoclopramide may also develop a serious blood disorder which affects red blood cells.
Driving and Operating Machinery
Metoclopramide may affect your ability to drive and operate machinery. Use caution when operating a car or dangerous machinery.
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 PRZ-METOCLOPRAMIDE:
- antipsychotic drugs which are used to manage psychosis, such as risperidone, quetiapine, olanzapine, paliperidone, and clozapine.
- drugs used to treat depression such as bupropion, fluoxetine, and paroxetine
- monoamine oxidase inhibitors which are used to treat depression, such as phenelzine
alcohol
- sedatives, sleep medication, narcotics, and other drugs that are used to treat anxiety such as phenobarbital, diazepam, clonazepam, and zolpidem
- digoxin, a heart medication
- drugs that increase dopamine concentrations and are used to treat various conditions such as Parkinson’s disease (example: bromocriptine and levodopa)
- anti-peristaltic drugs, such as loperamide, which are used to treat diarrhea.
The use of other drugs may require your doctor to adjust your dose of PRZ-METOCLOPRAMIDE or the dose of the other drug that you are taking. For example, the dose of digoxin may have to be increased because metoclopramide can change the way your body absorbs digoxin.
How to take PRZ-METOCLOPRAMIDE:
- Take PRZ-METOCLOPRAMIDE exactly as your healthcare professional has told you to.
- If you do not understand the directions, ask your healthcare professional to explain them to you.
- Swallow PRZ-METOCLOPRAMIDE tablets whole with water.
- Do not use two different forms of metoclopramide (tablets and oral solution) at the same time.
- You should only take PRZ-METOCLOPRAMIDE for longer than 12 weeks if your healthcare professional has told you that you can.
Note: PRZ-METOCLOPRAMIDE is only available as Tablets.
Usual dose:
Note: The total daily dosage for adults and children must not exceed 0.5 mg / kg body weight.
Your healthcare professional will tell you how much PRZ-METOCLOPRAMIDE to take and when to take it. The amount you are given will be based on your response to the medicine, your age, your body weight and other safety considerations. Your doctor may also adjust your dose if you have kidney or liver problems.
Overdose:
Missed Dose:
If you miss a dose, take another as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose to make up for a missed dose.
What are possible side effects from using PRZ-METOCLOPRAMIDE?
These are not all the possible side effects you may have when taking PRZ-METOCLOPRAMIDE. If you experience any side effects not listed here, tell your healthcare professional.
Common side effects may include:
- drowsiness
- fatigue
- insomnia
- headache
- dizziness
- bowel disturbances
If you think you, or a person you are caring for, have taken too much PRZ-METOCLOPRAMIDE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Allergic reaction: rash, hives, breathing difficulty, swelling of the mouth, throat and extremities. | ✓ | ||
Angioedema (swelling under the skin): redness, pain, or warmth in face, throat, arms, or hands, swelling of the face or mouth, difficulty breathing. | ✓ | ||
| Blood problems: increase or decrease of white blood cells, abnormalities in red blood cells. | ✓ | ||
Endocrine Disorders: abnormal breast discharge, enlarged breast tissue in males, impotence, changes in the menstrual cycle. | ✓ | ||
Feeling depressed or thoughts about hurting or killing yourself. | ✓ | ||
Heart problems: shortness of breath, sudden chest pain, pressure or discomfort, dizziness, feeling faint, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise, high blood pressure. | ✓ | ||
Hepatotoxicity (liver damage): yellowing of the skin and whites of the eyes, itching, abdominal pain, fatigue, loss of appetite, nausea, vomiting, rash, fever. | ✓ | ||
Neuroleptic Malignant Syndrome (serious neurological condition): muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, confusion or reduced consciousness. | ✓ | ||
Neurological reactions: convulsive seizures, hallucinations. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Parkinsonism or other extrapyramidal reactions (movement disorders): feeling restless, facial spasms, abnormal movements of head, jaw or eyeballs, muscular twitching, arching of the head, neck, and spine, slow movement, muscle stiffness, expressionless face. | ✓ | ||
Problems with urination and bladder control. | ✓ | ||
Tardive Dyskinesia (movement disorder): muscle twitching or unusual / abnormal movement of the face or tongue or other parts of your body. | ✓ | ||
| Visual disturbance: double vision, blurred vision, floaters, flashes of light. | ✓ | ||
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.
Storage:
Store between 15° and 30°C. Protect from light.
Do not use after the expiry date shown on the bottle.
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/adverse-reaction-reporting.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.
Keep out of reach and sight of children.
If you want more information about PRZ-METOCLOPRAMIDE:
- 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; or by calling the manufacturer’s phone number, 1-866-913-7955.
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