Patient Medication Information: uses, side effects, how to take - MYL-Pregabalin
What is the most important information I should know about MYL-PREGABALIN?
- 1.
MYL-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.
- 2.
MYL-PREGABALIN may cause dizziness and sleepiness.
Do not drive a car, work with machines, or do other
dangerous activities until you know how MYL-PREGABALIN affects how alert you are. Ask your doctor when it is okay to do these activities.
- 3. MYL-PREGABALIN may cause problems with your eyesight, including blurry vision. Call your doctor if you have any changes in your eyesight.
What the medication is used for:
MYL-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
MYL-PREGABALIN is also used for the symptomatic
relief of pain associated with fibromyalgia (a condition which includes widespread pain).
What it does:
MYL-PREGABALIN can relieve pain. Some patients taking pregabalin showed improvement as early as the first week of treatment.
When it should not be used:
You should not take MYL-PREGABALIN if you are allergic to pregabalin, the main ingredient in MYL-PREGABALIN, or any other ingredient in MYL-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 core are corn starch, lactose monohydrate, and talc.
The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulphate.
The markings on the capsules are in black ink, which contains black iron oxide, propylene glycol, potassium hydroxide, shellac and water.
What dosage forms 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 MYL-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. 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 MYL-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.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
| IMPORTANT: PLEASE READ |
Pregnancy Registry: If you become pregnant while taking MYL-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.massgeneral.org/aed/.
INTERACTIONS WITH THIS MEDICATION
While you are taking MYL-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. MYL-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 MYL-PREGABALIN:
- 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 MYL-PREGABALIN.
You can take MYL-PREGABALIN with or without food. Avoid alcoholic drinks while taking MYL-PREGABALIN.
Usual adult 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 room even if you do not feel 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 MYL-PREGABALIN with your next scheduled dose.
Do not suddenly stop taking MYL-PREGABALIN. Talk to your doctor first. Plan ahead to have a refill so you don't run out.
Some patients may have side effects while taking MYL-PREGABALIN. 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 MYL-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 MYL-PREGABALIN.
When MYL-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).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek emergency medical assistance | ||||
| Only if severe | In all cases | |||||
| Common | Dizziness Sleepiness Blurred vision | √ √ | √ | |||
| Uncommon | Weight gain Swelling of hands and feet (edema) Swelling of the face, mouth, lips, gums, neck or throat, | √ | √ | √ | ||
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| IMPORTANT: PLEASE READ |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek emergency medical assistance | ||||
| Only if severe | In all cases | |||||
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 MYL-PREGABALIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep MYL-PREGABALIN out of reach of children. Store it at controlled room temperature (15°C to 30°C) in the package it came in.
RE IT
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 www.healthcanada.gc.ca/medeffect
- 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 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
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.
M
MORE INFORMATION
ORE I
This document can be found at: www.mylan.caOR ION
The full product monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379