What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0102 .


Pregabalin Aspire 20mg/ml oral solution

Package leaflet: Information for the user

Pregabalin Aspire 20mg/ml oral solution

Pregabalin

Throughout this leaflet Pregabalin Aspire 20mg/ml oral solution will be called Pregabalin.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What this medicine is and what it is used for

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.

2. What you need to know before you take this medicine

Do not take this medicine

if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medicine

  • Some patients taking Pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
    Should you experience any of these reactions, you should contact your physician immediately.
  • Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have.
  • Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision.
  • Some patients with diabetes who gain weight while taking Pregabalin may need an alteration in their diabetic medicines.
  • 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 Pregabalin and the severity of these effects may be increased when taken together.
  • There have been reports of heart failure in some patients when taking Pregabalin; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your doctor if you have a history of heart disease.
  • There have been reports of kidney failure in some patients when taking Pregabalin. If while taking this medicine you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
  • A small number of people being treated with anti-epileptics such as Pregabalin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
  • When this medicine is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem.
  • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed.
  • There have been reports of convulsions when taking Pregabalin or shortly after stopping Pregabalin. If you experience a convulsion, contact your doctor immediately.
  • There have been reports of reduction in brain function(encephalopathy) in some patients taking Pregabalin when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
  • There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths.

Children and adolescents

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.

Other medicines and Pregabalin

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)

Alcohol

This medicine may be taken with oral contraceptives.

Pregabalin with food, drink and alcohol

This medicine may be taken with or without food.

It is advised not to drink alcohol while taking this medicine.

Pregnancy and breast-feeding

  • If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby.
  • If you are planning to become pregnant you should discuss your treatment with your doctor as early as possible before you become pregnant.
  • You should not stop your treatment without discussing this with your doctor.

Pregnancy

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.

Driving and using machines

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.

Pregabalin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Information on sodium content

This medicine contains less than 1mmol sodium (23mg) per maximum daily dose of 600mg (30ml), that is to say essentially ‘sodium-free’.

3. How to take this medicine

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.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:

  • Take the solution as instructed by your doctor.
  • The dose, which has been adjusted for you and your condition, will generally be between 150 mg (7.5 ml) and 600 mg (30 ml) each day.
  • Your doctor will tell you to take this medicine either twice or three times a day. For twice a day take this medicine once in the morning and once in the evening, at about the same time each day. For three times a day take this medicine once in the morning, once in the afternoon and once in the evening, at about the same time each day.

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.

Administration:

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.

If you take more of this medicine than you should

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.

If you forget to take this medicine

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.

If you stop taking this medicine

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.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

  • Dizziness, drowsiness, headache.

Common: may affect up to 1 in 10 people

  • Increased appetite.
  • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
  • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
  • Blurred vision, double vision.
  • Vertigo, problems with balance, fall.
  • Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
  • Difficulties with erection.
  • Swelling of the body including extremities.
  • Feeling drunk, abnormal style of walking.
  • Weight gain.
  • Muscle cramp, joint pain, back pain, pain in limbs.
  • Sore throat.

Uncommon: may affect up to 1 in 100 people

  • Loss of appetite, weight loss, low blood sugar, high blood sugar.
  • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
  • Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
  • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
  • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
  • Flushing, hot flushes.
  • Difficulty breathing, dry nose, nasal congestion.
  • Increased saliva production, heartburn, numbness around mouth.
  • Sweating, rash, chills, fever.
  • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
  • Breast pain.
  • Difficulty with or painful urination, incontinence.
  • Weakness, thirst, chest tightness.
  • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased, neutropaenia, increase in blood creatinine, decrease in blood potassium).
  • Hypersensitivity, swollen face, itchiness, hives, runny nose, nosebleed, cough, snoring.
  • Painful menstrual periods.
  • Coldness of hands and feet.

Rare: may affect up to 1 in 1000 people

  • Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
  • Dilated pupils, crossed eyes.
  • Cold sweat, tightness of the throat, swollen tongue.
  • Inflammation of the pancreas.
  • Difficulty in swallowing.
  • Slow or reduced movement of the body.
  • Difficulty with writing properly.
  • Increased fluid in the abdomen.
  • Fluid in the lungs.
  • Convulsions.
  • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
  • Muscle damage.
  • Breast discharge, abnormal breast growth, breast growth in males.
  • Interrupted menstrual periods.
  • Kidney failure, reduced urine volume, urinary retention.
  • Decrease in white blood cell count.
  • Inappropriate behaviour.
  • Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis) and a serious skin reaction characterized by rash, blisters, peeling skin and pain).
  • Jaundice (yellowing of the skin and eyes).

Very rare: may affect up to 1 in 10,000 people

  • Liver failure.
  • Hepatitis (inflammation of the liver).

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.

Reporting of side effects

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.

5. How to store 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.

6. Contents of the pack and other information

What this medicine contains

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 anhydrous, sucralose, strawberry flavouring 10131/P, purified water.

What this medicine looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder:

Aspire Pharma Ltd
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer:

One Pharma S.A
60th km N. N. R.
Athinon-Lamias
32 009 Sximatari Voiotias
Greece

This leaflet was last revised in: 09/2021

1010393-P6.1

PREG.ASPI.OR.LEAF.20.473.1