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: Pregabalin 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 is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin 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 treatment.

Generalised Anxiety Disorder: Pregabalin 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 the active substance 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 eye sight, 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 Pregabalin 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 Pregabalin 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 capsules

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

Pregabalin and certain other medicines may influence each other (interaction). When taken with certain other medicines, which have sedative effects (including opioids), Pregabalin 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 Pregabalin is taken together with medicinal products containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin may be taken with oral contraceptives.

Taking this medicine with food, drink and alcohol

Pregabalin capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin.

Pregnancy and breast-feeding

Pregabalin 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin 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.

3.How to take this medicine

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

Your doctor will determine what dose is appropriate for you. Pregabalin is for oral use only.

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

• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will

generally be between 150 mg and 600 mg each day.

• Your doctor will tell you to take Pregabalin either twice or three times a day. For twice a day take Pregabalin once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin 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 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 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.

Swallow the capsule whole with water.

Continue taking Pregabalin until your doctor tells you to stop.

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 Pregabalin capsules 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 your Pregabalin capsules 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 Pregabalin 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, XXXXXX

SAME SIZE ARTWORK 480 mm x 140 mm

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, pharmacist or nurse.

|                          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, neutropenia, 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 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 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 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 reactions has been reported in the post marketing experience: Trouble breathing, shallow breath.

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 at: 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.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• 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 this medicine contains

• The active substance is Pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are mannitol, maize starch, talc. The capsule shell contains gelatin, titanium dioxide (E171). In addition, 75mg, 100mg, 200mg, 225mg and 300mg capsules contain iron oxide red (E172). The printing ink composition is shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

What this medicine looks like and contents of the pack

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: Pregabalin 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 is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin 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 treatment.

Generalised Anxiety Disorder: Pregabalin 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 the active substance 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 eye sight, 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 Pregabalin 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 Pregabalin 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 sys tem 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 capsules

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

Pregabalin and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin 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 Pregabalin is taken together with medicinal products containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin may be taken with oral contraceptives.

Taking this medicine with food, drink and alcohol

Pregabalin capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin.

Pregnancy and breast-feeding

Pregabalin 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin 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.

3.How to take this medicine

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you. Pregabalin is for oral use only.

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

• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will

generally be between 150 mg and 600 mg each day.

• Your doctor will tell you to take Pregabalin either twice or three times a day. For twice a day take Pregabalin once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin 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 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 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.

Swallow the capsule whole with water.

Continue taking Pregabalin until your doctor tells you to stop.

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 Pregabalin capsules 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 your Pregabalin capsules 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 Pregabalin unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week.

SAME SIZE ARTWORK 480 mm x 140 mm

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, pharmacist or nurse.

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, neutropenia, 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 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 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 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 reactions has been reported in the post marketing experience: Trouble breathing, shallow breath

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 at: 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.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• 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 this medicine contains

• The active substance is Pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are mannitol, maize starch, talc. The capsule shell contains gelatin, titanium dioxide (E171). In addition, 75mg, 100mg, 200mg, 225mg and 300mg capsules contain iron oxide red (E172). The printing ink composition is shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

What this medicine looks like and contents of the pack

• 25 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘25’ on body with black ink, filled with white to off white powder.
• 50 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘50’ on body with black band, filled with white to off white powder.
• 75 mg capsules: Orange cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘75’ on body with black ink, filled with white to off white powder.
• 100 mg capsules: Orange cap / Orange body size ‘3’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘100’ on body with black ink, filled with white to off white powder.
• 150 mg capsules: White cap / White body size ‘2’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘150’ on body with black ink, filled with white to off white powder.
• 200 mg capsules: Orange cap / Orange body size ‘1’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘200’ on body with black ink, filled with white to off white powder.
• 225 mg capsules: Light orange cap / White body size ‘1’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘225’ on body with black ink, filled with white to off white powder.
• 300 mg capsules: Orange cap / White body size ‘0’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘300’ on body with black ink, filled with white to off white powder.
• This medicine is available in blister packs containing 14, 21, 56, 70, 84, 100 or 112 capsules. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email:

Manufacturer

axcount Generika GmbH

Max-Planck-StraBe 36 d

61381 Friedrichsdorf

Germany

Pregabalin 25mg Capsules, Hard; PL 17907/0584

Pregabalin 50mg Capsules, Hard; PL 17907/0585

Pregabalin 75mg Capsules, Hard; PL 17907/0586

Pregabalin 100mg Capsules, Hard; PL 17907/0587

Pregabalin 150mg Capsules, Hard; PL 17907/0588

Pregabalin 200mg Capsules, Hard; PL 17907/0589

Pregabalin 225mg Capsules, Hard; PL 17907/0590

Pregabalin 300mg Capsules, Hard; PL 17907/0591

This leaflet was last revised in August 2021

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

V10 09–08–21 D0

SAME SIZE ARTWORK 480 mm x 140 mm

Package leaflet: Information for the patient

Pregabalin 25 mg Capsules, Hard

Pregabalin 50 mg Capsules, Hard

Pregabalin 75 mg Capsules, Hard

Pregabalin 100 mg Capsules, Hard

Pregabalin 150 mg Capsules, Hard

Pregabalin 200 mg Capsules, Hard

Pregabalin 225 mg Capsules, Hard

Pregabalin 300 mg Capsules, Hard

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: Pregabalin 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 is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin 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 treatment.

Generalised Anxiety Disorder: Pregabalin 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 the active substance 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 eye sight, 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 Pregabalin 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 Pregabalin 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 sys tem 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 capsules

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

Pregabalin and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin 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 Pregabalin is taken together with medicinal products containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin may be taken with oral contraceptives.

Taking this medicine with food, drink and alcohol

Pregabalin capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin.

Pregnancy and breast-feeding

Pregabalin 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin 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.

3.How to take this medicine

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you. Pregabalin is for oral use only.

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

• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will

generally be between 150 mg and 600 mg each day.

• Your doctor will tell you to take Pregabalin either twice or three times a day. For twice a day take Pregabalin once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin 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 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 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.

Swallow the capsule whole with water.

Continue taking Pregabalin until your doctor tells you to stop.

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 Pregabalin capsules 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 your Pregabalin capsules 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 Pregabalin unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week.

SAME SIZE ARTWORK 480 mm x 140 mm

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, pharmacist or nurse.

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, neutropenia, 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 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 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 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 reactions has been reported in the post marketing experience: Trouble breathing, shallow breath

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 at: 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.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• 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.
• The active substance is Pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are mannitol, maize starch, talc. The capsule shell contains gelatin, titanium dioxide (E171). In addition, 75mg, 100mg, 200mg, 225mg and 300mg capsules contain iron oxide red (E172). The printing ink composition is shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

What this medicine looks like and contents of the pack

• 25 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘25’ on body with black ink, filled with white to off white powder.
• 50 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘50’ on body with black band, filled with white to off white powder.
• 75 mg capsules: Orange cap / White body size ‘4’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘75’ on body with black ink, filled with white to off white powder.
• 100 mg capsules: Orange cap / Orange body size ‘3’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘100’ on body with black ink, filled with white to off white powder.
• 150 mg capsules: White cap / White body size ‘2’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘150’ on body with black ink, filled with white to off white powder.
• 200 mg capsules: Orange cap / Orange body size ‘1’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘200’ on body with black ink, filled with white

to off white powder.

• 225 mg capsules: Light orange cap / White body size ‘1’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘225’ on body with black ink, filled with white to off white powder.
• 300 mg capsules: Orange cap / White body size ‘0’ hard gelatin capsules imprinted with ‘BL’ on cap and ‘300’ on body with black ink, filled with white to off white powder.
• This medicine is available in blister packs containing 14, 21, 56, 70, 84, 100 or 112 capsules. Not all pack sizes are marketed.