Patient Medication Information: uses, side effects, how to take - Pregabalin Oral Solution
Serious warnings and precautions box
What PREGABALIN ORAL SOLUTION is used for:
PREGABALIN ORAL SOLUTION is used in adults to treat pain caused by nerve damage due to:
- Diabetes
- Shingles
- Spinal cord injury
PREGABALIN ORAL SOLUTION is also used to treat pain associated with a condition called fibromyalgia (widespread pain)
How PREGABALIN ORAL SOLUTION works:
PREGABALIN ORAL SOLUTION works by decreasing the number of nerve signals in your body. This helps to calm down oversensitive nerve cells, which helps to relieve pain.
The ingredients in PREGABALIN ORAL SOLUTION are:
Medicinal ingredient: Pregabalin
Non-medicinal ingredients: Disodium hydrogen phosphate, methyl parahydroxybenzoate, propylene glycol, purified water, sodium dihydrogen phosphate monohydrate, strawberry flavour, sucralose.
PREGABALIN ORAL SOLUTION comes in the following dosage form(s):
Oral Solution: 20 mg/mL.
Do not use PREGABALIN ORAL SOLUTION if:
- You are allergic to pregabalin, or any other ingredient in PREGABALIN ORAL SOLUTION.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PREGABALIN ORAL SOLUTION. Talk about any health conditions or problems you may have, including if you:
- have any kidney problems.
| Taking PREGABALIN ORAL SOLUTION 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. |
- have any breathing problems or respiratory disease.
- are pregnant, plan to become pregnant, or think you might be pregnant.
- 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 PREGABALIN ORAL SOLUTION 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: PREGABALIN ORAL SOLUTION should not be taken during pregnancy. If you become pregnant while taking PREGABALIN ORAL SOLUTION, tell your healthcare professional right away. If you are taking PREGABALIN ORAL SOLUTION and are of childbearing age, you must use an effective method of birth control. If you take PREGABALIN ORAL SOLUTION during your first trimester of pregnancy, it can cause major birth defects in your unborn child.
Pregnancy Registry: If you become pregnant while taking PREGABALIN ORAL SOLUTION, 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 PREGABALIN ORAL SOLUTION, 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 PREGABALIN ORAL SOLUTION 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 PREGABALIN ORAL SOLUTION 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 it. If you feel like you are craving PREGABALIN ORAL SOLUTION, or not using it as directed, talk to a healthcare professional right away.
Driving and Using Machines: PREGABALIN ORAL SOLUTION may cause you to feel dizzy or sleepy. Wait until you know how PREGABALIN ORAL SOLUTION 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 PREGABALIN ORAL SOLUTION 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. Talk to your healthcare professional is you are unsure. |
|---|
The following may also interact with PREGABALIN ORAL SOLUTION:
- Benzodiazepines
- Medications used to treat diabetes, such as rosiglitazone, pioglitazone
How to take PREGABALIN ORAL SOLUTION:
- Take PREGABALIN ORAL SOLUTION exactly as your healthcare professional has told you to. [
- Do NOT stop taking PREGABALIN ORAL SOLUTION abruptly or you may experience unwanted side effects. If you have concerns with your treatment, talk to your healthcare professional first.
You can take PREGABALIN ORAL SOLUTION with or without food.
- Read the Instruction for use below for detailed instructions.
- Do not mix this medicine with food or beverages before use.
Instructions for use
Measure your dose using the oral syringe provided.
Step 1: Prepare PREGABALIN ORAL SOLUTION
- Remove the oral syringe and bottle adaptor from its protective case.
- Twist off bottle cap.
- Place the bottle on a flat surface. Push the bottle adaptor firmly into the bottle (see Figure 1). The bottle adaptor will stay in the bottle.
Figure 1
Step 2: Withdraw the prescribed dose
- Push the plunger all the way in. This will remove the air from the syringe.
- Insert syringe tip into the bottle adaptor (see Figure 2).
- Turn the bottle upside down. Pull the plunger to fill the syringe slightly past the amount of PREGABALIN ORAL SOLUTION needed (see Figure 3). This will help remove any air bubbles.
- Tap the syringe to move air bubbles to the top (see Figure 4). To remove air bubbles push the plunger so the top flat edge lines up with the desired dose. If you still see air bubbles, fill the syringe again, tap to move air bubbles to the tip and adjust dose.
- Turn the bottle right side up and remove the syringe from the bottle.
| Figure 2 | Figure 3 | Figure 4 |
|---|
Step 3: Deliver the dose
- Place the syringe gently into your mouth.
- Slowly press the plunger until the entire contents of the syringe is given.
- If your dose is greater than 5mL (100 mg), repeat steps 2 and 3 until you receive the entire prescribed dose.
Step 4: Rinse and store
- Twist the cap on the bottle to close. Do not remove the adaptor from the bottle.
- Using only water, rinse the syringe multiple times. Let it air dry.
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 PREGABALIN ORAL SOLUTION, contact a healthcare professional, hospital emergency department, 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. |
|---|
Missed dose:
If you missed a dose, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.
Possible side effects from using PREGABALIN ORAL SOLUTION:
These are not all the possible side effects you may have when taking PREGABALIN ORAL SOLUTION. 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 PREGABALIN ORAL SOLUTION
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Blurred vision | ✓ | ||
| Uncommon | |||
| 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 | ✓ | ||
| Angiodema: swelling of the face, mouth, lips, gums, neck or throat, trouble breathing, diarrhea, nausea or vomiting | ✓ | ||
| Decrease in the amount of urine | ✓ | ||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages | ✓ | ||
| Suicidal thoughts or actions | ✓ | ||
| Rare | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Kidney Failure: confusion, itchiness or rashes, puffiness in your face and hands, swelling in your feet or ankles, decreased amount of urine, weight gain | ✓ | ||
| 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 | ✓ | ||
| Unknown | |||
| Respiratory Depression (also known as hypoventilation): slow, shallow or weak breathing, blue lips, fingers or toes, confusion, headaches | ✓ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15°C - 25°C in its original package in an upright position. Discard 90 days after first opening.
Keep out of reach and sight of children.
If you want more information about PREGANALIN ORAL SOLUTION:
- 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); or calling at 1-888-666-6326.