Details for: APO-PREGABALIN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02394235 | APO-PREGABALIN | PREGABALIN | 25 MG | CAPSULE | ORAL |
| 02394243 | APO-PREGABALIN | PREGABALIN | 50 MG | CAPSULE | ORAL |
| 02394251 | APO-PREGABALIN | PREGABALIN | 75 MG | CAPSULE | ORAL |
| 02394278 | APO-PREGABALIN | PREGABALIN | 150 MG | CAPSULE | ORAL |
| 02394286 | APO-PREGABALIN | PREGABALIN | 225 MG | CAPSULE | ORAL |
| 02394294 | APO-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
APO-PREGABALIN is a prescription medicine used for the symptomatic relief of neuropathic pain associated with:
- Diabetic peripheral neuropathy (Pain from damaged nerves due to diabetes)
- Postherpetic neuralgia (Persisting pain following rash due to shingles)
- Pain from damaged nerves in the spinal cord
- APO-PREGABALIN is also used for the symptomatic relief of pain associated with fibromyalgia (a condition which includes widespread pain).
What it does
APO-PREGABALIN can relieve pain. Some patients taking Pregabalin showed improvement as early as the first week of treatment.
What is the most important information I should know about APO-PREGABALIN?
- APO-PREGABALIN may cause serious allergic reactions. Call your doctor right away if you think you have any of the following symptoms of a serious allergic reaction:
- swelling of the face, mouth, lips, gums, tongue or neck
- have any trouble breathing
- other allergic reactions may include rash, hives and blisters.
- Do not drive a car, work with machines, or do other dangerous activities until you know how APOPREGABALIN affects how alert you are. Ask your doctor when it is okay to do these activities.
When it should not be used
You should not take APO-PREGABALIN if you are allergic to pregabalin, the main ingredient in APOPREGABALIN, or any other ingredient in APOPREGABALIN (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 core are pregelatinised starch and purified talc.
The capsule shells contain gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the orange/red capsules shells contain red iron oxide.
The markings on the capsules are in black ink, which contains black iron oxide, propylene glycol, potassium hydroxide, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.
What dosage form it comes in
Capsules containing 25 mg, 50 mg, 75 mg, 150 mg, 225 mg or 300 mg of pregabalin.
Warnings and precautions
BEFORE you use APO-PREGABALIN, tell your doctor or pharmacist if
- you are taking any other prescription or 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. APO-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 APO-PREGABALIN or breast-feed, 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 heart failure.
- you have a history of lower gastrointestinal problems (eg., constipation, blocked or paralysed bowel), or you are taking medication(s) that may cause constipation.
Pregnancy Registry: If you become pregnant while taking APO-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 www.aedpregnancyregistry.org.
Interactions with this medication
While you are taking APO-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. APO-PREGABALIN does not interfere with birth control pills.
You may have a higher chance for dizziness and sleepiness if the following drugs are taken with APOPREGABALIN:
- Alcohol
- Medicines for anxiety (such as lorazepam)
- Narcotic pain medicine (such as oxycodone)
- Any medicines that 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 APO-PREGABALIN
Proper use of this medication
You can take APO-PREGABALIN with or without food. Avoid alcoholic drinks while taking APO-PREGABALIN.
Usual Dose
Your doctor will tell you how much to take and when to take it.
Overdose
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 APOPREGABALIN with your next scheduled dose.
Do not suddenly stop taking APO-PREGABALIN. Talk to your doctor first. Plan ahead to have a refill so you don't run out.
Side effects and what to do about them
Some patients may have side effects while taking APOPREGABALIN. Side effects are usually mild. In studies, few patients stopped taking 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 APO-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 APOPREGABALIN.
When APO-PREGABALIN is taken with other medications that may cause constipation (such as opioid pain medications), it is possible that gastrointestinal problems may occur (eg., constipation, blocked or paralysed bowel).
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Dizziness | ✔ | ||
| Sleepiness | ✔ | ||
| Blurred vision | ✔ | ||
| Uncommon | |||
| Weight gain | ✔ | ||
| Swelling of hands and feet (edema) | ✔ | ||
| Swelling of the face, mouth, lips, gums, neck or throat, trouble breathing | ✔ | ||
| Extreme fatigue | ✔ | ||
| Increased cough | ✔ | ||
| Allergic reactions (skin rash, hives, blisters) | ✔ | ||
| Decrease in 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 APO-PREGABALIN, contact your doctor or pharmacist.
How to store
Keep APO-PREGABALIN out of reach of children. Store at room temperature (15°C to 30°C).
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-healthproducts/medeffect-canada/adverse-reactionreporting.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 APO-PREGABALIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
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Date prepared: May 14, 2019