Patient Medication Information: uses, side effects, how to take - Apo-Metoclop Tab 5mg
ABOUT THIS MEDICATION
What the medication is used for:
APO-METOCLOP is a drug used to treat symptoms of slowed stomach emptying seen in people with gastritis, and in those recovering from certain types of gastric tests or surgery.
APO-METOCLOP, when used before surgery, can help reduce vomiting after surgical procedures.
What it does:
APO-METOCLOP is a drug used to help speed the movement of food through the stomach and intestines, by stimulating the muscles of the gastrointestinal tract.
When it should not be used:
Do not take APO-METOCLOP if you:
are allergic (hypersensitive) to metoclopramide or any of
the other ingredients listed in “What the non-medicinal ingredients are.”
are experiencing bleeding (hemorrhage), a blockage
(obstruction), or a tear (perforation) in your stomach or intestines
metoclopramide should not he used in children less than
1 year of age
What the medicinal ingredient is:
The active substance of APO-METOCLOP is metoclopramide hydrochloride.
What the important nonmedicinal ingredients are:
The non-medicinal ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
What dosage forms it comes in:
APO-METOCLOP is available in 5 mg and 10 mg tablets.
WARNINGS AND PRECAUTIONS
- A condition called tardive dyskinesia (see description below) has occurred with long-term (over 12 weeks) use of metoclopramide and even after long-term treatment has been stopped. The chance of this occurring increases with duration of treatment, total cumulative dose and in the elderly, particularly elderly women.
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.
- extrapyramidal symptoms ( e.g. shaking, tremor, stiffness and involuntary movement) may occur m children. Children's dosage should not exceed 0.5 mg/kg/day.
Before you use APO-METOCLOP be sure to tell your doctor or pharmacist 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 (e.g. epilepsy)
are pregnant. APO-METOCLOP should not be taken in pregnancy unless your doctor believes the benefit outweighs the risk to the fetus.
- are breastfeeding. Metoclopramide can pass into the breast milk and harm your baby. Talk to your doctor about the best way to feed your baby if you take metoclopramide
- have ever been diagnosed with breast cancer
- have kidney problems
- have an adrenal gland tumour called pheochromocytoma
Contact your doctor immediately if the following occur while taking metoclopramide:
- You develop symptoms of tardive dyskinesia or dystonia with symptoms such as involuntary movement of lips, eyes, tongue, face, head and limbs.
You develop Parkinson’s symptoms such as tremor,
restlessness, muscle rigidity, facial spasms, involuntary movements, and difficulty completing daily tasks.
You develop symptoms of neuroleptic malignant
syndrome with symptoms such as high temperature, muscle rigidity, irregular or fast heartbeat
You feel depressed or have thoughts about hurting or
killing yourself.
INTERACTIONS WITH THIS MEDICATION
Some medications may block the effects of
APO-METOCLOP, such as anticholinergic drugs. APO-METOCLOP may intensify the effect of alcohol and drugs absorbed from the intestines, such as neuroleptics.
Interactions may occur with monoamine oxidase inhibitors (e.g. some drugs used to treat depression).
Some drugs may increase the risk of drowsiness with APO-METOCLOP, such as sedatives, hypnotics, narcotics, and anxiolytics.
APO-METOCLOP may decrease the absorption of drugs from the stomach (e.g. digoxin) whereas
absorption from the small bowel may be accelerated (e.g. acetaminophen, tetracyclines, levodopa, alcohol).
PROPER USE OF THIS MEDICATION
Usual dose:
Note: The total adult and pediatric daily dosage must not exceed 0.5 mg/kg/body weight.
For Delayed Gastric Emptying
Adults: 5 to 10 mg 3 or 4 times a day before meals, depending upon response, body weight, and kidney function.
Children (5 to 14 years): 2.5 to 5 mg 3 times a day before meals, depending upon response and body weight.
Depending how well you respond to treatment and safety considerations, your dosage of APO-METOCLOP may be increased or decreased by your doctor, as appropriate.
Overdose:
In case of drug overdose, contact a health care practitioner ( or doctor), hospital emergency department or regional poison control centre, 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Common side effects
The most common side effects are drowsiness and fatigue.
Other possible common side effects include insomnia, headache, dizziness and bowel disturbances.
If any of these affects you severely, tell your doctor.
If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||||||||
| Symptom / effect | Talk with your | Stop taking | |||||||||
| doctor or | drug and | ||||||||||
| pharmacist | call your | ||||||||||
| Only if | In all | doctor or | |||||||||
| severe | cases | pharmacist | |||||||||
| Rare | Muscular twitching | √ | |||||||||
| Restlessness | √ | ||||||||||
| Facial Spasms or movements | √ | ||||||||||
| Unusual eye movements | √ | ||||||||||
| Involuntary or unusual movements | √ | ||||||||||
| Muscle rigidity | √ | ||||||||||
| Tremors | √ | ||||||||||
| High temperature, fast or irregular heartbeat | √ | ||||||||||
Feeling depressed or thoughts about hurting or killing yourself | √ | ||||||||||
Hypersensitivity (allergic) reaction with symptoms such as rash, hives, breathing difficulty, swelling of the mouth, throat and extremities | √ | ||||||||||
This is not a complete list of side effects. For any unexpected effects while taking APO-METOCLOP, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature (between 15 and 30°C) in tight, light resistant containers.
Do not use after the expiry date shown on the bottle.
Keep out of the reach and sight of children.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
Last revised: July 21, 2014
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.