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Pregabalin Aspire 20mg/ml oral solution
Pregabalin Aspire 20mg/ml oral solution
Throughout this leaflet Pregabalin Aspire 20mg/ml oral solution will be called Pregabalin.
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: This medicine is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Epilepsy: This medicine is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation-epileptic fits starting on one specific part of the brain) in adults. Your doctor will prescribe this medicine for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take this medicine in addition to your current treatment. Pregabalin is not intended to be used alone, but should always be used in combination with other anti-epileptic treatments.
Generalised Anxiety Disorder: This medicine is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday life.
if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking this medicine
The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This medicine and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), this medicine may potentiate these effects and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if this medicine is taken together with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
This medicine may be taken with oral contraceptives.
This medicine may be taken with or without food.
It is advised not to drink alcohol while taking this medicine.
This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential.
There has been limited research specifically looking at the use of pregabalin in pregnant women. A recent study suggested that women who took pregabalin while they were pregnant might have a slightly higher chance of having a baby born with physical birth abnormalities. More research is needed to better understand and inform on the safety of use of pregabalin during pregnancy and whether it is associated with an increased risk of harm to the unborn child.
This medicine may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1mmol sodium (23mg) per maximum daily dose of 600mg (30ml), that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take this medicine normally except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Continue taking this medicine until your doctor tells you to stop.
Instructions for use
This medicine is for oral use only.
1. Open the bottle: Press downward on the cap and turn it counter-clockwise (Figure 1).
2. First time use only: A Press-In Bottle Adapter (PIBA) is provided with the oral syringe. This is the device that gets inserted into the neck of the bottle to make it easier to withdraw the solution using the oral syringe. If the PIBA is not already in place, remove the PIBA and 5ml oral syringe from the plastic overwrap. With the bottle on a flat surface, insert the PIBA into the bottle neck while keeping the PIBA’s flat surface facing up and pressing on it (Figure 2).
3. Push the syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air. Attach the syringe to the PIBA with a slight twisting motion (Figure 3).
4. Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the syringe plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4). Remove air bubbles from the syringe by pushing the plunger up to the appropriate graduation mark.
5. Return the bottle to an upright position with the syringe still in the PIBA/bottle (Figure 5).
6. Remove the syringe from the bottle/PIBA (Figure 6).
7. Empty the contents of the syringe directly into the mouth by pushing the syringe plunger to the bottom of the syringe barrel (Figure 7).
Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1). [For example, a 150mg (7.5ml) dose will require two withdrawals from the bottle to achieve the entire dose. Using the oral syringe, first withdraw 5ml and empty contents of syringe directly into the mouth, then refill the oral syringe with 2.5ml and empty the remaining contents into the mouth.]
8. Rinse the syringe by drawing water into the syringe and pushing the syringe plunger to the bottom of the syringe barrel, at least three times (Figure 8).
9. Replace the cap on the bottle (leaving the PIBA in place in the bottle neck) (Figure 9).
Oral Syringe Withdrawals to Deliver Prescribed Dose of Pregabalin
Pregabalin Dose 25mg:
Total solution volume 1.25ml. First syringe withdrawal 1.25ml, Second syringe withdrawal not required, Third syringe withdrawal not required.
Pregabalin Dose 50mg:
Total solution volume 2.5ml. First syringe withdrawal 2.5ml, Second syringe withdrawal not required, Third syringe withdrawal not required.
Pregabalin Dose 75mg:
Total solution volume 3.75ml. First syringe withdrawal 3.75ml, Second syringe withdrawal not required, Third syringe withdrawal not required.
Pregabalin Dose 100mg:
Total solution volume 5ml. First syringe withdrawal 5ml, Second syringe withdrawal not required, Third syringe withdrawal not required.
Pregabalin Dose 150mg:
Total solution volume 7.5ml. First syringe withdrawal 5ml, Second syringe withdrawal 2.5ml, Third syringe withdrawal not required.
Pregabalin Dose 200mg:
Total solution volume 10ml. First syringe withdrawal 5ml, Second syringe withdrawal 5ml, Third syringe withdrawal not required.
Pregabalin Dose 225mg:
Total solution volume 11.25ml. First syringe withdrawal 5ml, Second syringe withdrawal 5ml, Third syringe withdrawal 1.25ml.
Pregabalin Dose 300mg:
Total solution volume 15ml. First syringe withdrawal 5ml, Second syringe withdrawal 5ml, Third syringe withdrawal 5ml.
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of this medicine with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin than you should. Fits have also been reported.
It is important to take this medicine regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.
Do not stop taking this medicine unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week.
After stopping long and short-term Pregabalin treatment, you need to know that you may experience certain side effects. These include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness. These symptoms may occur more commonly or severely if you have been taking Pregabalin for a longer period of time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10,000 people
If you experience a swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to this medicine and the severity of these effects may be increased when taken together.
The following adverse reaction has been reported in the postmarketing experience: Trouble breathing, shallow breaths.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www. mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Once opened, the contents of the bottle should be used within 60 days.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is pregabalin. Each ml contains 20mg of pregabalin.
The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate anhydrous, disodium hydrogen phosphate, sucralose, strawberry flavouring 10131/P, purified water.
Pregabalin Aspire 20mg/ml oral solution is a clear colourless solution in a white bottle containing 473ml of oral solution, in a cardboard carton.
The carton also contains a graduated 5ml oral syringe and a press-in bottle adapter (PIBA).
Marketing Authorisation Holder:
This leaflet was last revised in: 03/2023