Pregabalin Brillpharma 20mg/ml Oral Solution – patient leaflet, side effects, dosage

1. What Pregabalin Brillpharma is and what it is used for

Pregabalin Brillpharma belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

It contains pregabalin which belongs to a class of medicines called Gabapentinoids.

This medicine has been prescribed to you and should not be given to anyone else.

Pregabalin can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.

Peripheral and central neuropathic pain: Pregabalin Brillpharma 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: Pregabalin Brillpharma 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 Pregabalin Brillpharma for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Brillpharma in addition to your current treatment. Pregabalin Brillpharma is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Brillpharma 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 Pregabalin Brillpharma

Do not take Pregabalin Brillpharma:

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

Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Pregabalin Brillpharma • Some patients taking Pregabalin Brillpharma 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 Brillpharma 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 Brillpharma 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 Brillpharma 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 Brillpharma; 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 Brillpharma. If while taking Pregabalin Brillpharma 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 Brillpharma have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

• When Pregabalin Brillpharma 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.

• if you are or have ever been addicted to opioids, alcohol, prescription

  medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake. • if you have previously suffered from withdrawal symptoms such

  as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

• if you feel you need to take more of Pregabalin Brillpharma to get

  the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.

• There have been reports of convulsions when taking Pregabalin

  Brillpharma or shortly after stopping Pregabalin Brillpharma. If you experience a convulsion, contact your doctor immediately.

• There have been reports of reduction in brain function

  (encephalopathy) in some patients taking Pregabalin Brillpharma 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.

Dependence

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have ex-plained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is

usually done gradually over a period which is specific to you and may occur over a period of weeks to months. Physical dependence and addiction can cause

withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to expe-rience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Pregabalin Brillpharma should only be used by those they are pre-scribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of Pregabalin Brillpharma, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.

Children and adolescents

The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, Pregabalin Brillpharma should not be used in this age group.

Other medicines and Pregabalin Brillpharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregabalin Brillpharma and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids). Pregabalin Brillpharma may potentiate the side effects seen with these medicines, including respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Brillpharma is taken together with medicines containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin Brillpharma may be taken with oral contraceptives.

Pregabalin Brillpharma with food, drink and alcohol

Pregabalin Brillpharma may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Brillpharma.

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

Pregabalin Brillpharma 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 re search 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.

Pregabalin use during the first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the nervous system (including the brain), kidneys and genitals have been reported.

Driving and using machines

Pregabalin Brillpharma 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 Brillpharma contains methyl parahydroxy benzoate, ethyl parahydroxybenzoate and sodium

Pregabalin Brillpharma contains methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214), which may cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol sodium (23 mg) per dose (7.5 ml to 30 ml), that is to say essentially ‘sodium-free’.

3. How to take Pregabalin Brillpharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your prescriber should have discussed with you how long the course of Pregabalin will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

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

• Take the oral 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 Pregabalin Brillpharma either

  twice or three times a day. For twice a day take Pregabalin Brillpharma once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Brillpharma 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 Pregabalin Brillpharma 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 Pregabalin Brillpharma 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 Pregabalin Brillpharma until your doctor tells you to stop.

Administration:

Instructions for use

Pregabalin Brillpharma is for oral use only;

1. 1.

   Open the bottle: Press downward on the cap

   and turn it counter-clockwise (Figure 1).

   Figure 1

2. 2.

   First time use only: An Adaptor 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 adaptor is not already in

   place, remove the adaptor and 5 ml oral

   syringe from the plastic overwrap. With the

   bottle on a flat surface, insert the adaptor into

   the bottle neck while keeping flat surface of the

   adaptor facing up and pressing on it (Figure 2).

   Figure 2

200 mm

1. 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 adaptor

   with a slight twisting motion (Figure 3).

   Figure 3

2. 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.

   Figure 4

3. 5.

   Return the bottle to an upright position with the

   syringe still in the adaptor/bottle (Figure 5).

   Figure 5

4. 6.

   Remove the syringe from the

   bottle/adaptor (Figure 6).

5. 7.

   Empty the contents of the syringe directly

   into the side of the mouth by pushing the

   syringe plunger to the bottom of the syringe

   barrel (Figure 7).

   Figure 6

   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 150 mg (7.5 ml) dose will require two withdrawals from the bottle to achieve the entire dose. Using the oral syringe, first withdraw 5 ml and empty contents of syringe directly into the side of the mouth, then refill the oral syringe with 2.5 ml and empty the remaining contents into the side of the mouth.]

1. 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).

   Figure 8

2. 9.

   Replace the cap on the bottle

   (leaving the adaptor in place in the

   bottle neck) (Figure 9).

   Figure 9

Table 1 Oral Syringe Withdrawals to Deliver Prescribed Dose of Pregabalin Brillpharma 20mg/ml Oral solution

If you take more Pregabalin Brillpharma than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Brillpharma with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Brillpharma than you should. Fits and unconsciousness (coma) have also been reported.

If you forget to take Pregabalin Brillpharma

It is important to take your Pregabalin Brillpharma 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 Pregabalin Brillpharma

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

After stopping long and short-term Pregabalin Brillpharma treatment, you need to know that you may experience certain side effects so called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness. These effects may occur more commonly or severely if you have been taking Pregabalin Brillpharma for a longer period of time. If you experience withdrawal effects, you should contact your doctor. 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 limb - 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 attacks, 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, numb 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, nose bleed, cough, snoring.
  • Painful menstrual periods.
  • Coldness of hands and feet.

Rare: may affect up to 1 in 1,000 people

• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
• Dilated pupils, cross 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 reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).

• Parkinsonism, that is symptoms resembling Parkinson’s disease;

  such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).

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

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

Not known: frequency cannot be estimated from the available data

• dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

Drug Withdrawal

When you stop taking Pregabalin, you may experience drug withdrawal symptoms, which include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Pregabalin, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose - You are using the medicine for reasons other than prescribed - When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

If you experience 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 Pregabalin Brillpharma and the severity of these effects may be increased when taken together.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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, pharmacist or nurse. 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 Pregabalin Brillpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle label and on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not use after 130 days of first opening the bottle.

Do not throw away any medicines 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 Pregabalin Brillpharma contains

• The active substance is Pregabalin. Each 1 ml of oral solution contains 20 mg of Pregabalin.

• The other ingredients are: methyl parahydroxybenzoate

  (E218), ethyl parahydroxybenzoate (E214), monosodium phosphate dihydrate (E339), disodium phosphate dihydrate (E339), sucralose (E955), strawberry flavour, purified water.

What Pregabalin Brillpharma looks like and contents of the pack

Pregabalin Brillpharma is a clear colourless oral solution in a white bottle with child resistant closure, containing 473 ml of oral solution, in a carton.

The carton also contains a 5 ml oral syringe with graduation of 1.25 ml equivalent to 25 mg of pregabalin and an adaptor.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Brillpharma Limited,

6 Sovereign Park, Luton, LU4 8EL, United Kingdom Telephone: 0044 (0) 1582 545500

Email: info@brillpharma.co.uk

Manufacturer

Wave Pharma Limited,

4th Floor, Cavendish House, 369 Burnt Oak Broadway, Edgware, HA8 5AW, United Kingdom

Pregabalin Brillpharma 20mg/ml Oral Solution; PL 40496/0008 This leaflet was last revised in November 2025

To request a copy of this leaflet in Braille, large print or audio format then please contact the marketing authorisation holder at the address (telephone or email) above.

V14 04-11-25 D0

200 mm