GABAPENTIN 800MG FILM-COATED TABLETS
Active substance: GABAPENTIN
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PATIENT INFORMATION LEAFLET Gabapentin 600 mg & 800 mg film-coated Tablets
Gabapentin
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Gabapentin Tablets are and what they are used for 2. Before you take Gabapentin Tablets 3. How to take Gabapentin Tablets 4. Possible side effects 5. How to store Gabapentin Tablets 6. Further information 1. WHAT GABAPENTIN TABLETS ARE AND WHAT THEY ARE USED FOR Gabapentin Tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). Gabapentin is used to treat: Various forms of epilepsy Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms) 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. 2. BEFORE YOU TAKE GABAPENTIN TABLETS Do not take Gabapentin Tablets if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin Tablets Take special care with Gabapentin Tablets if you suffer from kidney problems if you are on haemodialysis, 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 (these may be symptoms of acute pancreatitis). 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. Contact your doctor immediately if you experience these symptoms. Taking other medicines Some medicines can affect the way Gabapentin Tablets work, or Gabapentin Tablets themselves can reduce the effectiveness of other medicines taken at the same time. These include: any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin Tablets. Antacids, as absorption of Gabapentin Tablets from the stomach may be reduced. It is therefore recommended that Gabapentin Tablets are taken at the earliest two hours after taking an antacid.
Taking Gabapentin Tablets with food and drink Gabapentin Tablets can be taken with or without food. Pregnancy Gabapentin Tablets should not be taken during pregnancy, unless you are told otherwise by your doctor. If you discover you are pregnant, do not suddenly discontinue taking this medicine as this may lead to serious consequences for you and your baby. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Tablets. Effective contraception must be used by women of child-bearing age. Breastfeeding Gabapentin, the active substance of Gabapentin Tablets, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Tablets unless told to do so by your doctor. Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines Gabapentin Tablets may produce dizziness, drowsiness and tiredness. If you experience these symptoms, do not drive, or use any tools or machinery until you know whether this medication affects your ability to perform these activities. 3. HOW TO TAKE GABAPENTIN TABLETS Always take Gabapentin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you. Always swallow the tablets whole with plenty of water. Continue taking Gabapentin Tablets until your doctor tells you to stop. Epilepsy: Adults and adolescents: Take the number of tablets as instructed. 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. 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 childs 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 per kg of body weight per day. It is usually given in 3 separate doses, by taking the tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin Tablets are not recommended for use in children below 6 years of age. Peripheral Neuropathic Pain: Adults: Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually. The usual 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. Elderly: If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin Tablets unless you have problems with your kidneys. If you have kidneys problems or are receiving haemodialysis Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidney or are undergoing haemodialysis.
If you have the impression that the effect of Gabapentin Tablets is too strong or too weak, talk to your doctor or pharmacist, as soon as possible If you take more Gabapentin Tablets than you should Higher than recommended doses may result in an increase in undesirable effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately. Take along any tablets 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 Tablets 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 Tablets Do not stop taking Gabapentin Tablets 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 Tablets suddenly or before your doctor tells you, there is an increased risk of seizures, pain or discomfort. Adverse events following the abrupt discontinuation of gabapentin include the following: anxiety, difficulty sleeping, feeling sick, pain, sweating and chest pain. Please tell your doctor if you have any of the following symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Gabapentin Tablets can cause side effects, although not everybody gets them: Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious: swelling of the lips and face, skin rash and redness and/or hair loss (these may be symptoms of a serious allergic reaction) If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness persistent stomach pain, feeling sick and being sick (these may be symptoms of acute pancreatitis) Other side effects include: Very common side effects (which may affect more than 1 person in 10) Dizziness, lack of coordination, viral infection, feeling drowsy, feeling tired, fever. Common side effects (which may affect 1 to 10 persons in 100) Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes. Pneumonia, respiratory infection, urinary tract infection, infection, 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. Also blurred vision, double vision, vertigo, high blood pressure, flushing or dilation of blood vessels, difficulty breathing, bronchitis, sore throat, cough, dry or runny nose, vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence (wind). Facial swelling, bruises, rash, itch, acne, joint pain, muscle pain, back pain, twitching, difficulties with erection, 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.
Uncommon side effects (which may affect 1-10 persons in 1000) 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 Since introduction to the market the following side-effects have been reported: Acute kidney failure, incontinence Inammation of the pancreas Inammation of the liver, yellowing of the skin and eyes (jaundice) Hallucinations Problems with abnormal movements such as writhing, jerking movements and stiffness Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating, chest pain) Increased breast tissue, breast enlargement Decreased platelets (blood clotting cells) Ringing in the ears Blood glucose uctuations in patients with diabetes If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE GABAPENTIN TABLETS Keep out of the reach and sight of children. Do not use Gabapentin Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store Gabapentin Tablets above 25C. Store in the original package in order to protect from moisture Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Gabapentin Tablets contain The active substance is gabapentin . Each film-coated tablet contains either 600 mg or 800 mg gabapentin. The other ingredients in Gabapentin Tablets are: Tablet core: Poloxamer type 407, Copovidone, Sodium Starch Glycolate type A, Hydrogenated vegetable oil, Talc, Colloidal silica anhydrous. Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc. What Gabapentin Tablets look like and contents of the pack Gabapentin 600 mg film-coated tablets are white oval film-coated tablets embossed with '600', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets. Not all pack sizes may be marketed. Gabapentin 800 mg film-coated tablets are white oval film-coated tablets embossed with '800', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Rivopharm UK, 6th oor, 28 Kingsway, London WC2B 6JR, UK Manufacturer SynerLAB - Laboratoires BTT Zone Industrielle de Krat 67150 Erstein, FRANCE Distributed by: Creo Pharma Ltd Felsted Business Centre Felsted, Essex, CM6 3LY This leaflet was last approved in {MM/YYYY}
Gabapentin Tablets may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking. You should not take Gabapentin Tablets in addition to your current treatment unless told otherwise. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Gabapentin
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Gabapentin Tablets are and what they are used for 2. Before you take Gabapentin Tablets 3. How to take Gabapentin Tablets 4. Possible side effects 5. How to store Gabapentin Tablets 6. Further information 1. WHAT GABAPENTIN TABLETS ARE AND WHAT THEY ARE USED FOR Gabapentin Tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). Gabapentin is used to treat: Various forms of epilepsy Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms) 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. 2. BEFORE YOU TAKE GABAPENTIN TABLETS Do not take Gabapentin Tablets if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin Tablets Take special care with Gabapentin Tablets if you suffer from kidney problems if you are on haemodialysis, 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 (these may be symptoms of acute pancreatitis). 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. Contact your doctor immediately if you experience these symptoms. Taking other medicines Some medicines can affect the way Gabapentin Tablets work, or Gabapentin Tablets themselves can reduce the effectiveness of other medicines taken at the same time. These include: any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gabapentin Tablets. Antacids, as absorption of Gabapentin Tablets from the stomach may be reduced. It is therefore recommended that Gabapentin Tablets are taken at the earliest two hours after taking an antacid.
Taking Gabapentin Tablets with food and drink Gabapentin Tablets can be taken with or without food. Pregnancy Gabapentin Tablets should not be taken during pregnancy, unless you are told otherwise by your doctor. If you discover you are pregnant, do not suddenly discontinue taking this medicine as this may lead to serious consequences for you and your baby. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Tablets. Effective contraception must be used by women of child-bearing age. Breastfeeding Gabapentin, the active substance of Gabapentin Tablets, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Tablets unless told to do so by your doctor. Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines Gabapentin Tablets may produce dizziness, drowsiness and tiredness. If you experience these symptoms, do not drive, or use any tools or machinery until you know whether this medication affects your ability to perform these activities. 3. HOW TO TAKE GABAPENTIN TABLETS Always take Gabapentin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you. Always swallow the tablets whole with plenty of water. Continue taking Gabapentin Tablets until your doctor tells you to stop. Epilepsy: Adults and adolescents: Take the number of tablets as instructed. 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. 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 childs 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 per kg of body weight per day. It is usually given in 3 separate doses, by taking the tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin Tablets are not recommended for use in children below 6 years of age. Peripheral Neuropathic Pain: Adults: Take the number of tablets as instructed by your doctor. Your doctor will usually build up your dose gradually. The usual 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. Elderly: If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin Tablets unless you have problems with your kidneys. If you have kidneys problems or are receiving haemodialysis Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidney or are undergoing haemodialysis.
If you have the impression that the effect of Gabapentin Tablets is too strong or too weak, talk to your doctor or pharmacist, as soon as possible If you take more Gabapentin Tablets than you should Higher than recommended doses may result in an increase in undesirable effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately. Take along any tablets 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 Tablets 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 Tablets Do not stop taking Gabapentin Tablets 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 Tablets suddenly or before your doctor tells you, there is an increased risk of seizures, pain or discomfort. Adverse events following the abrupt discontinuation of gabapentin include the following: anxiety, difficulty sleeping, feeling sick, pain, sweating and chest pain. Please tell your doctor if you have any of the following symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Gabapentin Tablets can cause side effects, although not everybody gets them: Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious: swelling of the lips and face, skin rash and redness and/or hair loss (these may be symptoms of a serious allergic reaction) If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness persistent stomach pain, feeling sick and being sick (these may be symptoms of acute pancreatitis) Other side effects include: Very common side effects (which may affect more than 1 person in 10) Dizziness, lack of coordination, viral infection, feeling drowsy, feeling tired, fever. Common side effects (which may affect 1 to 10 persons in 100) Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes. Pneumonia, respiratory infection, urinary tract infection, infection, 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. Also blurred vision, double vision, vertigo, high blood pressure, flushing or dilation of blood vessels, difficulty breathing, bronchitis, sore throat, cough, dry or runny nose, vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence (wind). Facial swelling, bruises, rash, itch, acne, joint pain, muscle pain, back pain, twitching, difficulties with erection, 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.
Uncommon side effects (which may affect 1-10 persons in 1000) 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 Since introduction to the market the following side-effects have been reported: Acute kidney failure, incontinence Inammation of the pancreas Inammation of the liver, yellowing of the skin and eyes (jaundice) Hallucinations Problems with abnormal movements such as writhing, jerking movements and stiffness Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating, chest pain) Increased breast tissue, breast enlargement Decreased platelets (blood clotting cells) Ringing in the ears Blood glucose uctuations in patients with diabetes If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE GABAPENTIN TABLETS Keep out of the reach and sight of children. Do not use Gabapentin Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store Gabapentin Tablets above 25C. Store in the original package in order to protect from moisture Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Gabapentin Tablets contain The active substance is gabapentin . Each film-coated tablet contains either 600 mg or 800 mg gabapentin. The other ingredients in Gabapentin Tablets are: Tablet core: Poloxamer type 407, Copovidone, Sodium Starch Glycolate type A, Hydrogenated vegetable oil, Talc, Colloidal silica anhydrous. Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc. What Gabapentin Tablets look like and contents of the pack Gabapentin 600 mg film-coated tablets are white oval film-coated tablets embossed with '600', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets. Not all pack sizes may be marketed. Gabapentin 800 mg film-coated tablets are white oval film-coated tablets embossed with '800', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Rivopharm UK, 6th oor, 28 Kingsway, London WC2B 6JR, UK Manufacturer SynerLAB - Laboratoires BTT Zone Industrielle de Krat 67150 Erstein, FRANCE Distributed by: Creo Pharma Ltd Felsted Business Centre Felsted, Essex, CM6 3LY This leaflet was last approved in {MM/YYYY}
Gabapentin Tablets may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking. You should not take Gabapentin Tablets in addition to your current treatment unless told otherwise. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
