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 Pregabalin Amarox is and what it is used for

• 2. What you need to know before you take Pregabalin Amarox

• 3. How to take Pregabalin Amarox

• 4. Possible side effects

• 5. How to store Pregabalin Amarox

• 6. Contents of the pack and other information

1. what pregabalin amarox is and what it is used for

Pregabalin Amarox 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 Amarox 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 Amarox is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Amarox for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Amarox in addition to your current treatment. Pregabalin Amarox is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Amarox 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 amarox

Do not take Pregabalin Amarox:

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 Pregabalin Amarox.

• Some patients taking Pregabalin Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox; 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 Amarox. If while taking Pregabalin Amarox 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 Amarox have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• When Pregabalin Amarox 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 Amarox or shortly after stopping Pregabalin Amarox. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Amarox 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 Amarox should not be used in this age group.

Other medicines and Pregabalin Amarox

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

Pregabalin Amarox and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Amarox 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 Amarox is taken together with medicines containing: Oxycodone – (used as a pain-killer) Lorazepam – (used for treating anxiety) Alcohol

Pregabalin Amarox may be taken with oral contraceptives.

Pregabalin Amarox with food, drink and alcohol

Pregabalin Amarox capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Amarox.

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.

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 childbearing 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.

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 Amarox 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 Amarox contains sodium and mannitol

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‚sodium-free‘.

Mannitol may have a mild laxative effect.

3. how to take pregabalin amarox

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

If you take more Pregabalin Amarox than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Amarox capsules with you.

You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Amarox than you should. Fits have also been reported.

If you forget to take Pregabalin Amarox

It is important to take your Pregabalin Amarox 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 Pregabalin Amarox

Do not stop taking Pregabalin Amarox 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 Amarox 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 Amarox 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 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 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 heart beat, 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 rash, blisters, peeling skin and pain).
• 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).

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 Amarox 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website 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 amarox

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 blister and carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 informationwhat pregabalin amarox containsthe active substance is pregabalin.

Each capsule, hard contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg & 300 mg pregabalin.

The other ingredients are:

Capsule contents : Mannitol, maize starch & talc

Capsule shell : Gelatin, sodium lauryl sulphate, titanium dioxide (E171)

The 75mg, 100mg, 200mg, 225mg, 300mg capsules also contain Iron Oxide Red (E172).

Printing ink : shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.

What Pregabalin Amarox looks like and contents of the pack

Capsule, hard

Pregabalin Amarox 25 mg

White cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚138‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 50 mg

White cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚139‘ on cap with a black band and ‚J‘ on body with a black band, filled with white to off white powder.

Pregabalin Amarox 75 mg

Orange cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚140‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 100 mg

Orange cap / Orange body size ‚3‘ hard gelatin capsules imprinted with ‚141‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 150 mg

White cap / White body size ‚2‘ hard gelatin capsules imprinted with ‚142‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 200 mg

Orange cap / Orange body size ‚1‘ hard gelatin capsules imprinted with ‚143‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 225 mg

Light orange cap / White body size ‚1‘ hard gelatin capsules imprinted with ‚144‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 300 mg

Orange cap / White body size ‚0‘ hard gelatin capsules imprinted with ‚145‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox capsules are available in clear PVC-Alu blister packs containing 56 and 84 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amarox Limited

Congress House, 14 Lyon Road

Harrow, Middlesex HA1 2EN

United Kingdom

Manufacturer

Amarox Limited

Congress House, 14 Lyon Road

Harrow, Middlesex HA1 2EN

United Kingdom

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This leaflet was last revised in 12/2021.

Package leaflet: Information for the user Pregabalin Amarox 25 mg capsules Pregabalin Amarox 50 mg capsules Pregabalin Amarox 75 mg capsules Pregabalin Amarox 100 mg capsules Pregabalin Amarox 150 mg capsules Pregabalin Amarox 200 mg capsules Pregabalin Amarox 225 mg capsules Pregabalin Amarox 300 mg capsules 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 Pregabalin Amarox is and what it is used for

• 2. What you need to know before you take Pregabalin Amarox

• 3. How to take Pregabalin Amarox

• 4. Possible side effects

• 5. How to store Pregabalin Amarox

• 6. Contents of the pack and other information

1. what pregabalin amarox is and what it is used for

Pregabalin Amarox 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 Amarox 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 Amarox is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Amarox for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Amarox in addition to your current treatment. Pregabalin Amarox is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Amarox 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 amarox

Do not take Pregabalin Amarox:

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 Pregabalin Amarox.

• Some patients taking Pregabalin Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox; 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 Amarox. If while taking Pregabalin Amarox 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 Amarox have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• When Pregabalin Amarox 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 Amarox or shortly after stopping Pregabalin Amarox. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Amarox 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 Amarox should not be used in this age group.

Other medicines and Pregabalin Amarox

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

Pregabalin Amarox and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Amarox 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 Amarox is taken together with medicines containing: Oxycodone – (used as a pain-killer) Lorazepam – (used for treating anxiety) Alcohol

Pregabalin Amarox may be taken with oral contraceptives.

Pregabalin Amarox with food, drink and alcohol

Pregabalin Amarox capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Amarox.

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.

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 childbearing 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.

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 Amarox 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 Amarox contains sodium and mannitol

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‚sodium-free‘.

Mannitol may have a mild laxative effect.

3. how to take pregabalin amarox

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

If you take more Pregabalin Amarox than you should

Call your doctor or go to the nearest hospital emergency unit immediately.

Take your box or bottle of Pregabalin Amarox capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Amarox than you should. Fits have also been reported.

If you forget to take Pregabalin Amarox

It is important to take your Pregabalin Amarox 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 Pregabalin Amarox

Do not stop taking Pregabalin Amarox 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 Amarox 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 Amarox 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 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 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 heart beat, 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 rash, blisters, peeling skin and pain).
• 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).

5. how to store pregabalin amarox

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 blister and carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 informationwhat pregabalin amarox containsthe active substance is pregabalin.

Each capsule, hard contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg & 300 mg pregabalin.

The other ingredients are:

Capsule contents : Mannitol, maize starch & talc

Capsule shell : Gelatin, sodium lauryl sulphate, titanium dioxide (E171)

The 75mg, 100mg, 200mg, 225mg, 300mg capsules also contain Iron Oxide Red (E172).

Printing ink : shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.

What Pregabalin Amarox looks like and contents of the pack

Capsule, hard

Pregabalin Amarox 25 mg

White cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚138‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 50 mg

White cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚139‘ on cap with a black band and ‚J‘ on body with a black band, filled with white to off white powder.

Pregabalin Amarox 75 mg

Orange cap / White body size ‚4‘ hard gelatin capsules imprinted with ‚140‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 100 mg

Orange cap / Orange body size ‚3‘ hard gelatin capsules imprinted with ‚141‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 150 mg

White cap / White body size ‚2‘ hard gelatin capsules imprinted with ‚142‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 200 mg

Orange cap / Orange body size ‚1‘ hard gelatin capsules imprinted with ‚143‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 225 mg

Light orange cap / White body size ‚1‘ hard gelatin capsules imprinted with ‚144‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox 300 mg

Orange cap / White body size ‚0‘ hard gelatin capsules imprinted with ‚145‘ on cap and ‚J‘ on body with black ink, filled with white to off white powder.

Pregabalin Amarox capsules are available in clear PVC-Alu blister packs containing 56 and 84 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amarox Limited

Congress House, 14 Lyon Road

Harrow, Middlesex HA1 2EN

United Kingdom

Manufacturer

Amarox Limited

Congress House, 14 Lyon Road

Harrow, Middlesex HA1 2EN

United Kingdom

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This leaflet was last revised in 12/2021.

Package leaflet: Information for the user Pregabalin Amarox 25 mg capsules Pregabalin Amarox 50 mg capsules Pregabalin Amarox 75 mg capsules Pregabalin Amarox 100 mg capsules Pregabalin Amarox 150 mg capsules Pregabalin Amarox 200 mg capsules Pregabalin Amarox 225 mg capsules Pregabalin Amarox 300 mg capsules 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 Pregabalin Amarox is and what it is used for

• 2. What you need to know before you take Pregabalin Amarox

• 3. How to take Pregabalin Amarox

• 4. Possible side effects

• 5. How to store Pregabalin Amarox

• 6. Contents of the pack and other information

1. what pregabalin amarox is and what it is used for

Pregabalin Amarox 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 Amarox 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 Amarox is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Amarox for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Amarox in addition to your current treatment. Pregabalin Amarox is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Amarox 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 amarox

Do not take Pregabalin Amarox:

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 Pregabalin Amarox.

• Some patients taking Pregabalin Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox 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 Amarox; 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 Amarox. If while taking Pregabalin Amarox 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 Amarox have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• When Pregabalin Amarox 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 Amarox or shortly after stopping Pregabalin Amarox. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Amarox 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 Amarox should not be used in this age group.

Other medicines and Pregabalin Amarox

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

Pregabalin Amarox and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Amarox 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 Amarox is taken together with medicines containing: Oxycodone – (used as a pain-killer) Lorazepam – (used for treating anxiety) Alcohol

Pregabalin Amarox may be taken with oral contraceptives.

Pregabalin Amarox with food, drink and alcohol

Pregabalin Amarox capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Amarox.

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.

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 childbearing 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.

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 Amarox 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 Amarox contains sodium and mannitol

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‚sodium-free‘.

Mannitol may have a mild laxative effect.

3. how to take pregabalin amarox

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

If you take more Pregabalin Amarox than you should

Call your doctor or go to the nearest hospital emergency unit immediately.

Take your box or bottle of Pregabalin Amarox capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Amarox than you should. Fits have also been reported.

If you forget to take Pregabalin Amarox

It is important to take your Pregabalin Amarox 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 Pregabalin Amarox

Do not stop taking Pregabalin Amarox 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 Amarox 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 Amarox 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 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 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 heart beat, 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 rash, blisters, peeling skin and pain).
• 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).