Details for: AG-PREGABALIN
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02480727 | AG-PREGABALIN | PREGABALIN | 25 MG | CAPSULE | ORAL |
| 02480735 | AG-PREGABALIN | PREGABALIN | 50 MG | CAPSULE | ORAL |
| 02480743 | AG-PREGABALIN | PREGABALIN | 75 MG | CAPSULE | ORAL |
| 02480751 | AG-PREGABALIN | PREGABALIN | 150 MG | CAPSULE | ORAL |
| 02480778 | AG-PREGABALIN | PREGABALIN | 300 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AG-Pregabalin is a prescription medicine used for the symptomatic reliefof neuropathic pain associated with:
- Diabetic peripheral neuropathy (Pain from damaged nervesdue to diabetes)
- Postherpetic neuralgia (Persisting pain following rash due to shingles)
- AG-Pregabalin is also used for the symptomatic relief of pain associated with fibromyalgia (a condition which includes widespreadpain)
What it does
AG-Pregabalin can relieve pain. Some patients taking AG-Pregabalin showed improvement as early asthe first week of treatment.
When it should not be used
You should not take AG-Pregabalin if you are allergic to pregabalin, the main ingredient in AGPregabalin, or any other ingredient in AG-Pregabalin (see “What the non- medicinal ingredients are”). Children under the age of 18 years.
What the medicinal ingredient is
Pregabalin
What the non-medicinal ingredients are
The non-medicinal ingredients that make up the capsule fill are Pregelatinized starch, and talc.
The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide
The markings on the capsules are in black ink, which contains black iron oxide, butyl alcohol dehydrated alcohol, Isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, shellac and water.
What dosage form it comes in
Capsules containing 25, 50, 75, 150 or 300 mg of pregabalin.
Warnings and precautions
Serious Warnings and Precautions
Taking AG-Pregabalin with opioid medicines, alcohol, or other central nervoussystem depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
BEFORE you use AG-Pregabalin tell your doctor or pharmacistif:
- you are taking any other prescription medicines including narcotic pain medicines like oxycodone, nonprescription medicines, or natural/herbal remedies.
- you have any kidney problems.
- you are pregnant, plan to become pregnant, or think you might be pregnant.
- you are breastfeeding. AG-Pregabalin passes into breast milk and it is not known if it can harm your baby. You and your healthcare provider should discuss whether you should take AG-Pregabalin or breastfeed, but you should not do both.
- you have ever had an allergic reaction (itching, wheezing, hives, or swelling of the throat or face) to pregabalin or any of the nonmedicinal ingredients listed in “What the nonmedicinal ingredients are”.
- you have a history of heart disease called congestive heartfailure.
- you have a history of lower gastrointestinal problems (e.g., constipation ,blocked or paralyzed bowel), or you are taking medication(s)thatmaycause constipation.
Pregnancy Registry: If you become pregnant while taking AG-Pregabalin, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888- 233-2334. The purpose of this registry is to collect information about the safety of anticonvulsant medicines during pregnancy. Any woman who is currently pregnant and is taking antiepileptic drugs for any reason, can enroll in the registry. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
Interactions with this medication
While you are taking AG-Pregabalin, don't start any new medicines, including natural or herbal medicines, without talking to your doctor first. Your doctor or pharmacist will know which medicines are safe for you to take together. AG-Pregabalin does not interfere withbirth control pills.
You may have a higher chance for dizziness and sleepiness if the following drugs are taken with AG-Pregabalin:
- Alcohol
- Medicinesfor anxiety(such aslorazepam)
- Narcoticpainmedicine(such asoxycodone)
- Any medicinesthat make you sleepy
You may have a higher chance of weight gain or swelling if the antidiabetic pills, Avandia (rosiglitazone) or Actos (pioglitazone) are taken with AG-Pregabalin.
Proper use of this medication
You can take AG-Pregabalin with or without food. Avoid alcoholic drinks while taking AG-Pregabalin.
Usual Dose
Your doctor will tell you how much to take and when to take it.
Overdose
In case of a drug overdose, immediately go to the nearest emergency roomeven if you do notfeel sick. Make sure you take your medicine bottle with you to show the doctor.
Missed Dose
If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, do NOT take the missed capsules. Simply wait and restart AGPregabalin with your nextscheduled dose.
Do not suddenly stop taking AG-Pregabalin. Talk to your doctor first. Plan ahead to have a refill so you don'trun out.
Side effects and what to do about them
Some patients may have side effects while taking AGPregabalin. Side effects are usually mild. In studies, few patients stopped taking AG-Pregabalin due to side effects.
The most common side effects were: dizziness, sleepiness, blurred vision, dry mouth, swelling of the extremities, weight gain, trouble concentrating, lack of energy, muscle weakness, constipation, and forgetfulness.
A small number of patients taking a drug of this type may experience thoughts of suicide. Your doctor should be informed immediately if this occurs.
When you start AG-Pregabalin, you may get sleepy or experience dizziness. Avoid potentially hazardous tasks: do not drive a car or operate machinery until you are sure that this medication does not affect your ability to drive or operate machinery or until you get used to AGPregabalin.
When AG-Pregabalin is taken with other medications that may cause constipation (such as opioid pain medications), it is possible that gastrointestinal problems may occur(e.g., constipation, blocked or paralyzed bowel)
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek emergency medical assistance |
|---|---|---|---|
| Common | |||
| Dizziness | ✔ | ||
| Sleepiness | ✔ | ||
| Blurred vision | ✔ | ||
| Uncommon | |||
| Weight gain | ✔ | ||
| Swelling of hands and feet (edema) | ✔ | ||
| Swelling ofthe face,mouth, lips, gums, neck or throat, trouble breathing | ✔ | ||
| Extreme fatigue | ✔ | ||
| Increased cough | ✔ | ||
| Allergicreactions (skin rash, hives, blisters) | ✔ | ||
| Decreasein the amount of urine | ✔ | ||
| Thoughts of suicide | ✔ | ||
| Very rare | |||
| Seizures | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects while taking AG-Pregabalin, contact your doctor or pharmacist.
How to store
Keep AG-Pregabalin out of reach and sight of children. Store it at room temperature (15°C to 30°C) in the package it came in from the doctor or pharmacist.
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/healthcanada/services/drugs-health-products/medeffectcanada/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.
More information
If you want more information about AG-Pregabalin:
- 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://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp)orthe manufacturer’s website (www.angitapharma.in),or by calling 450-449-9272.
Thisleaflet was prepared by:
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Revision Date: October 27, 2020