Gabapentin Teva 600mg Film-Coated Tablets
TEVA UK Ref: 231-30-63706-ZA LEA GABAPENTIN A/S TAB TUK Version: 1 7 October 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
GABAPENTIN Teva 600 mg and 800 mg Film-coated TABLETS
Gabapentin
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Gabapentin is and what it is used for
2. What you need to know before you take Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Contents of the pack and other information
What Gabapentin is and what it is used for
Gabapentin belongs to a group of medicines used to
treat epilepsy and peripheral neuropathic pain (long-
lasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Tablets is
gabapentin.
Gabapentin is used to treat:
• various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Your doctor will prescribe Gabapentin for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin in addition to your current treatment unless told otherwise.
• Gabapentin can also be used on its own to treat adults and children over 12 years of age.
Peripheral neuropathic pain
• peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) 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, etc.
©What you need to know before you take Gabapentin
DO not take Gabapentin:
• if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6)..
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin
• if you suffer from kidney problems your doctor may prescribe a different dosing schedule • if you are on haemodialysis (to remove waste
products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness • if you develop signs such as persistent stomach pain, feeling sick and being sick; contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas).
Cases of abuse and dependence have been reported for gabapentin from the post- marketing experience. Talk to your doctor if you have a history of abuse or dependence.
A small number of people being treated with anti-epileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions
A small number of people taking Gabapentin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated.You need to know these symptoms to look out for while you are taking Gabapentin.
Read the description of these symptoms in section 4 of this leaflet under 'Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious'
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing morphine If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin.
Antacids for indigestion
If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that Gabapentin is taken at the earliest two hours after taking an antacid.
• Gabapentin is not expected to interact with other anti-epileptic drugs or the oral contraceptive pill.
• Gabapentin may interfere with some laboratory tests; if you require a urine test tell your doctor or hospital that you are taking Gabapentin.
Gabapentin with food and drink
• Gabapentin can be taken with or without food.
Pregnancy and breast-feeding
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.
Pregnancy
Gabapentin should not be taken during pregnancy,
unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential.
There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the foetus, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin.
Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
Breast-feeding
Gabapentin, the active substance of Gabapentin Tablets, is excreted in human milk. Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using Gabapentin.
Driving and using machines
Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
How to take Gabapentin
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.
For lower dosages, which cannot be applied with these strengths, other strengths and dosage forms are available.
If you have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
If you have kidney problems or are receiving haemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.
Continue taking Gabapentin until your doctor tells you to stop.
The recommended dose for treating epilepsy
Adults and adolescents:
Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually.
• The starting dose will generally be between 300 mg and 900 mg each day.
• Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Children aged 6 years and above:
The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
• The usual dose to control epilepsy is 25-35 mg/kg/day. It is usually given in 3 divided, doses, by taking the tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Top of page cut-off to middle of registration mark: 44 mm.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
a
Gabapentin is not recommended for use in children below 6 years of age.
The recommended dose for treating Peripheral Neuropathic Pain:
Adults:
Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
Method and route of administration
Gabapentin is for oral use. Always swallow the tablets whole with plenty of water.
If you take more Gabapentin than you should
If you or someone else accidentally takes too many tablets, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin tablets may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, loss of consciousness, drowsiness and mild diarrhea.Take along any tablets that are left that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken.
If you forget to take Gabapentin
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Gabapentin
DO NOT stop taking Gabapentin unless your doctor tells you to.
If your treatment is stopped, it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin suddenly or before your doctor tells you, there is an increased risk of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
• severe skin reactions such as swelling of the lips and face, skin rash and redness, and/or hair loss.
• persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
• Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin. Call your doctor right away if you have any of the following symptoms:
• Skin rash
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of your lip and tongue
• Yellowing of your skin or of the whites of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common (may affect more than 1 in 10 people):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever.
Common (may affect up to 1 in 10 people):
• Pneumonia, respiratory infection, urinary tract infection, other infections, inflammation of the ear
• Low white blood cell counts
• Anorexia, increased appetite
• Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking
• Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes
• Blurred vision, double vision
• Vertigo
• High blood pressure, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruises, rash, itch, acne
• Joint pain, muscle pain, back pain, twitching
• Difficulties with erection (impotence)
• Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
• Decrease in white blood cells, increase in weight
• Accidental injury, fracture, abrasion.
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Uncommon (may affect up to 1 in 100 people):
• Allergic reaction such as hives
• Decreased movement
• Racing heartbeat
• Swelling that may involve the face, trunk and limbs
• Abnormal blood test results suggesting problems with the liver.
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in patients with diabetes)
Rare (may affect up to 1 in 1,000 people):
• Loss of consciousness
• Low blood sugar (most often observed in patients with diabetes)
Since introduction to the market the following side-effects have been reported:
• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together
• Inflammation of the liver, yellowing of the skin and eyes (jaundice)
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase increased)
• Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
• Hyponatraemia
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Gabapentin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
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.
Contents of the pack and other information What Gabapentin Teva contains
• The active substance is gabapentin. Each film-coated tablet contains either 600 mg or 800 mg gabapentin.
• The other ingredients are:
Core: povidone, cellulose, microcrystalline, crospovidone, talc, hydrogenated vegetable (soyabean) oil Type I
Coating: hypromellose, titanium dioxide (E171), macrogol 400.
What Gabapentin Teva looks like and contents of the pack
• Gabapentin 600 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7173” on one side, and "93” on the other side.
• Gabapentin 800 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7174” on one side, and "93” on the other side.
• Gabapentin Tablets are available in blister packs of 10, 28, 50, 84, 90, 100 or 200 tablets, or in bottles (HDPE) of 28, 50, 90, 100, 200 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: September 2015
PL 00289/0593-0594
TZHZD
63706-ZA
PAGE 1: FRONT FACE (INSIDE OF REEL)
GABAPENTIN Teva 600 mg and 800 mg Film-coated TABLETS
Gabapentin
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Gabapentin is and what it is used for
2. What you need to know before you take Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Contents of the pack and other information
What Gabapentin is and what it is used for
Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Tablets is gabapentin.
Gabapentin is used to treat:
• various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Your doctor will prescribe Gabapentin for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin in addition to your current treatment unless told otherwise.
• Gabapentin can also be used on its own to treat adults and children over 12 years of age.
Peripheral neuropathic pain
• peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) 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, etc.
©What you need to know before you take Gabapentin
DO not take Gabapentin:
• if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6)..
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin
• if you suffer from kidney problems your doctor may prescribe a different dosing schedule • if you are on haemodialysis (to remove waste
products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness • if you develop signs such as persistent stomach pain, feeling sick and being sick; contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas).
Cases of abuse and dependence have been reported for gabapentin from the post- marketing experience. Talk to your doctor if you have a history of abuse or dependence.
A small number of people being treated with anti-epileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions
A small number of people taking Gabapentin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know these symptoms to look out for while you are taking Gabapentin.
Read the description of these symptoms in section 4 of this leaflet under 'Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious'
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing morphine If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin.
Antacids for indigestion
If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that Gabapentin is taken at the earliest two hours after taking an antacid.
• Gabapentin is not expected to interact with other anti-epileptic drugs or the oral contraceptive pill.
• Gabapentin may interfere with some laboratory tests; if you require a urine test tell your doctor or hospital that you are taking Gabapentin.
Gabapentin with food and drink
• Gabapentin can be taken with or without food.
Pregnancy and breast-feeding
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.
Pregnancy
Gabapentin should not be taken during pregnancy,
unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential.
There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the foetus, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin.
Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
Breast-feeding
Gabapentin, the active substance of Gabapentin Tablets, is excreted in human milk. Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using Gabapentin.
Driving and using machines
Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
^3^ How to take Gabapentin
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.
For lower dosages, which cannot be applied with these strengths, other strengths and dosage forms are available.
If you have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin unless you have problems with your kidneys.Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
If you have kidney problems or are receiving haemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.
Continue taking Gabapentin until your doctor tells you to stop.
The recommended dose for treating epilepsy
Adults and adolescents:
Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually.
• The starting dose will generally be between 300 mg and 900 mg each day.
• Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Children aged 6 years and above:
The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
• The usual dose to control epilepsy is 25-35 mg/kg/day. It is usually given in 3 divided, doses, by taking the tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
3
Pharma code TBC
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.
What Gabapentin Teva contains
• The active substance is gabapentin. Each film-coated tablet contains either 600 mg or 800 mg gabapentin.
• The other ingredients are:
Core: povidone, cellulose, microcrystalline, crospovidone, talc, hydrogenated vegetable (soyabean) oil Type I
Coating: hypromellose, titanium dioxide (E171), macrogol 400.
Not all pack sizes may be marketed.
Gabapentin is not recommended for use in children below 6 years of age.
The recommended dose for treating Peripheral Neuropathic Pain:
Adults:
Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually.
The starting dose will generally be between 300 mg and 900 mg each day.Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
Method and route of administration
Gabapentin is for oral use. Always swallow the tablets whole with plenty of water.
If you take more Gabapentin than you should
If you or someone else accidentally takes too many tablets, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin tablets may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, loss of consciousness, drowsiness and mild diarrhea. Take along any tablets that are left that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken.
If you forget to take Gabapentin
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Gabapentin
DO NOT stop taking Gabapentin unless your doctor tells you to.
If your treatment is stopped, it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin suddenly or before your doctor tells you, there is an increased risk of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
• severe skin reactions such as swelling of the lips and face, skin rash and redness, and/or hair loss.
• persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
• Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin. Call your doctor right away if you have any of the following symptoms:
• Skin rash
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of your lip and tongue
• Yellowing of your skin or of the whites of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common (may affect more than 1 in 10 people):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever.
Common (may affect up to 1 in 10 people):
• Pneumonia, respiratory infection, urinary tract infection, other infections, inflammation of the ear
• Low white blood cell counts
• Anorexia, increased appetite
• Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking
• Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes
• Blurred vision, double vision
• Vertigo
• High blood pressure, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruises, rash, itch, acne
• Joint pain, muscle pain, back pain, twitching
• Difficulties with erection (impotence)
• Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
• Decrease in white blood cells, increase in weight
• Accidental injury, fracture, abrasion.
Additionally in clinical studies in children, aggressive
behaviour and jerky movements were reported
commonly.
Uncommon (may affect up to 1 in 100 people):
• Allergic reaction such as hives
• Decreased movement
• Racing heartbeat
• Swelling that may involve the face, trunk and limbs
• Abnormal blood test results suggesting problems with the liver.
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in patients with diabetes)
Rare (may affect up to 1 in 1,000 people):
• Loss of consciousness
• Low blood sugar (most often observed in patients with diabetes)
Since introduction to the market the following side-effects have been reported:
• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together
• Inflammation of the liver, yellowing of the skin and eyes (jaundice)
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase increased)
• Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
• Hyponatraemia 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Gabapentin
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package. 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.
Contents of the pack and other information
What Gabapentin Teva looks like and contents of the
pack
• Gabapentin 600 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7173" on one side, and "93" on the other side.
• Gabapentin 800 mg Tablets are white to off-white, oval shaped, bevelled edged, film-coated tablets, engraved "7174" on one side, and "93" on the other side.
• Gabapentin Tablets are available in blister packs of 10, 28, 50, 84, 90, 100 or 200 tablets, or in bottles (HDPE) of 28, 50, 90, 100, 200 or 500 tablets.
Marketing Authorisation Holder- TEVA UK Limited, Eastbourne, BN22 9AG, England Company responsible for manufacture:Teva
pharmaceutical works private limited company, Pallagi ut 13, 4042 Debrecen, Hungary
This leaflet was last revised: September 2015
PL 00289/0593-0594
26541-E
REG0076652 Version 3.7 Approved Page 2 of 3