Patient Medication Information: uses, side effects, how to take - Apo-Pregabalin
Serious Warnings and Precautions
Taking APO-PREGABALIN with opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
What is APO-PREGABALIN used for?
APO-PREGABALIN is used in adults to treat pain caused by nerve damage due to:
- Diabetes
- Shingles
- Spinal cord injury
APO-PREGABALIN is also used to treat pain associated with a condition called fibromyalgia (widespread pain).
How does APO-PREGABALIN work?
APO-PREGABALIN works by decreasing the number of nerve signals in your body. This helps to calm down oversensitive nerve cells, which helps to relieve pain.
What are the ingredients in APO-PREGABALIN?
Medicinal ingredients: Pregabalin
Non-medicinal ingredients: Capsule core: pregelatinised starch and purified talc. Capsule shells: 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, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.
APO-PREGABALIN comes in the following dosage forms:
Capsules: 25 mg, 50 mg, 75 mg, 150 mg, 225 mg or 300 mg.
Do not use APO-PREGABALIN if:
- You are allergic to pregabalin, or any other ingredient in APO-PREGABALIN.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-PREGABALIN. Talk about any health conditions or problems you may have, including if you:
- have any kidney problems.
- have any breathing problems or respiratory disease.
- are pregnant, plan to become pregnant, or think you might be pregnant.
- 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.
- have ever had an allergic reaction to any other drug.
- have a history of heart disease or heart failure.
- have a history of lower gastrointestinal problems (e.g., constipation, blocked or paralysed bowel), or you are taking medication(s) that may cause constipation.
- have current or a history of addiction or substance abuse, misuse, physical dependence or withdrawal.
Other warnings you should know about:
Pregnancy: APO-PREGABALIN should not be taken during pregnancy. If you become pregnant while taking APO-PREGABALIN, tell your healthcare professional right away. If you are taking APO-PREGABALIN and are of childbearing age, you must use an effective method of birth control. If you take APO-PREGABALIN during your first trimester of pregnancy, it can cause major birth defects in your unborn child.
Pregnancy Registry: If you become pregnant while taking APO-PREGABALIN, talk to your healthcare professional 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.
Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/.
Eye Problems: If you experience any changes in your vision while taking APO-PREGABALIN, tell your healthcare professional right away. If you already have eye problems, your healthcare professional may recommend that you have more frequent eye exams.
Stopping Your Medication: Do NOT stop taking APO-PREGABALIN without discussing it with your healthcare professional first. Stopping your treatment abruptly may cause you to experience unwanted side effects including insomnia, nausea, headache, anxiety, excessive sweating and diarrhea. Convulsions have occurred in non-epileptic patients.
Stopping your treatment must be a gradual process that you discuss with your healthcare professional. If you have any concerns with your treatment, talk to your healthcare professional.
Dependence/Tolerance: Even when APO-PREGABALIN has been taken exactly as directed, there have been some cases of abuse, misuse, addiction, physical dependence and withdrawal. Your healthcare professional will monitor you while you are taking APO-PREGABALIN. If you feel like you are craving APO-PREGABALIN, or not using it as directed, talk to a healthcare professional right away.
Driving and Using Machines: APO-PREGABALIN may cause you to feel dizzy or sleepy. Wait until you know how APO-PREGABALIN affects you before performing tasks that require special attention.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do NOT take APO-PREGABALIN with opioid medicines, alcohol, or other central nervous system depressants (including street drugs). this can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. |
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The following may interact with APO-PREGABALIN:
- Alcohol
- Opioid medicines
- Benzodiazepines
- Medications used to treat diabetes, such as rosiglitazone, pioglitazone
How to take APO-PREGABALIN:
- Take APO-PREGABALIN exactly as your healthcare professional has told you to.
- Do NOT stop taking APO-PREGABALIN abruptly or you may experience unwanted side effects. If you have concerns with your treatment, talk to your healthcare professional first.
You can take APO-PREGABALIN with or without food.
Usual dose:
Your healthcare professional has decided the best dose for you and will tell you how much to take and when to take it.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-PREGABALIN, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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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 APO-PREGABALIN with your next scheduled dose.
What are possible side effects from using APO-PREGABALIN?
These are not all the possible side effects you may have when taking APO-PREGABALIN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Dizziness
- Sleepiness
- Headache
- Nausea
- Dry mouth
- Increased cough
- Weight gain
- Trouble concentrating
- Forgetfulness
- Lack of energy
- Muscle weakness
Constipation; talk with your healthcare professional about ways to prevent constipation
- when you start using APO-PREGABALIN.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Blurred vision | √ | ||
| UNCOMMON | |||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages | √ | ||
| Angiodema: swelling of the face, mouth, lips, gums, neck or throat, trouble breathing, diarrhea, nausea or vomiting | √ | ||
| Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | √ | ||
| Decrease in the amount of urine | √ | ||
| Suicidal thoughts or actions | √ | ||
| RARE | |||
| Kidney Failure: confusion, itchiness or rashes, puffiness in your face and hands, swelling in your feet or ankles, decreased amount of urine, weight gain | √ | ||
| UNKNOWN | |||
| Respiratory Depression (also known as hypoventilation): slow, shallow or weak breathing, blue lips, fingers or toes, confusion, headaches | √ | ||
| VERY RARE | |||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness. | √ | ||
| Severe Skin Reactions: fever, severe rash, swollen lymph glands, | √ | ||
| flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | |||
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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store at room temperature (15°C to 30°C) in the package it came in.
Keep out of reach and sight of children.
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 the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.