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GABAPENTIN 400 MG CAPSULES
gabapentin #400 mg caps
gabapentin #400 mg caps
6. FURTHER INFORMATION What Gabapentin contains: The active substance is gabapentin. Each capsule, hard contains either 100 mg, 300 mg or 400 mg gabapentin. The other ingredients in Gabapentin capsules are: lactose, maize starch, talc, gelatin and titanium dioxide (E171). The 300 mg and 400 mg also contain iron oxides (E172). What Gabapentin looks like and contents of the pack: The 100 mg capsules are white, the 300 mg capsules are yellow and the 400 mg capsules are orange.
Each 400 mg hard capsule contains: 400 mg of gabapentin. This product contains: lactose monohydrate. Read the package leaflet before use. For oral use. Take as directed by the doctor. Keep out of the reach and sight of children. Do not store above 25C. Keep the container tightly closed.
PL 4569/0667 POM 10003794 LL0444AD Mylan, Potters Bar, Herts, EN6 1TL
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400 mg Gabapentin 400 mg Hard Capsules
100 Hard Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 100 mg HARD CAPSULES GABAPENTIN 300 mg HARD CAPSULES GABAPENTIN 400 mg HARD CAPSULES
5. HOW TO STORE GABAPENTIN Keep out of the reach and sight of children. Do not use Gabapentin after the expiry date, which is shown on the label, carton or bottle after 'EXP'. The expiry date refers to the last day of that month. Store the capsules below 25 C. Keep the bottle tightly closed. Keep the blister strip in the outer carton. 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.
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.
Gabapentin capsules are available in blister packs of 10, 20, 30, 50, 90, 100, 200, 250 or 1000 capsules or in containers of 50, 100 or 250 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder : Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Generics [UK] Limited, Potters bar, Herts, EN6 1TL, United Kingdom.
Date of revision: 03/2012
If any of the side eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What GABAPENTIN is and what it is used for 2. Before you take GABAPENTIN 3. How to take GABAPENTIN 4. Possible side eects 5. How to store GABAPENTIN 6. Further information 1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain.
Epilepsy: 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: Gabapentin is used to treat long lasting pain caused by damage to the nerves. A variety of dierent
Acute kidney failure. Adverse events following the abrupt discontinuation of gabapentin (anxiety, diculty sleeping, feeling sick, pain, sweating), chest pain. Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver. Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly. If any of the side eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist.
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. 2. BEFORE YOU TAKE GABAPENTIN Do not take Gabapentin if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin. Take special care with Gabapentin if you suer from kidney problems
if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately. 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. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are taking any medicines containing morphine, please tell your doctor or
Rare side-effects: (aects 1 to 10 users in 10,000): Decreased platelets (blood clotting cells). Allergic reaction such as hives. Hallucinations. Problems with abnormal movements such as writhing, jerking movements and stiness. Ringing in the ears. Racing heartbeat. Inflammation of the pancreas. Inflammation of the liver, yellowing of the skin and eyes. Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss.
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. Incontinence. Diculties with erection. Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, diculty with walking, weakness, pain, feeling unwell, flu-like symptoms. Decrease in white blood cells, increase in weight. Accidental injury, fracture, abrasion.
pharmacist as morphine may increase the eect of Gabapentin. Gabapentin is not expected to interact with other antiepileptic 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. 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.
Taking Gabapentin with food and drink Gabapentin can be taken with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Gabapentin should not be taken during pregnancy, unless you are told otherwise by your doctor. Eective 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.
Low white blood cell counts. Anorexia, increased appetite. Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, diculty with thinking. Convulsions, jerky movements, diculty with speaking, loss of memory, tremor, diculty sleeping, headache, sensitive skin, decreased sensation, diculty with co-ordination, unusual eye movement, increased, decreased or absent reflexes. Blurred vision, double vision. Vertigo. High blood pressure, flushing or dilation of blood vessels. Diculty breathing, bronchitis, sore throat,
4. POSSIBLE SIDE EFFECTS Like all medicines, Gabapentin can cause side eects, although not everybody gets them. Very common side-effects: (aects more than 1 user in 10): Viral infection. Feeling drowsy, dizziness, lack of co-ordination. Feeling tired, fever. Common side-effects: (aects 1 to 10 users in 100): Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear.
Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy. Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have 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. Gabapentin, the active substance of Gabapentin, is excreted in human milk. Because the eect 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 aects your ability to perform these activities. Important information about some of the ingredients of Gabapentin The capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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 product, ask your doctor or pharmacist.
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 capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin is not recommended for use in children below 6 years of age. If you take more Gabapentin than you should Call your doctor or go to the nearest hospital emergency unit immediately. Take along any capsules that are left, the container and the label so that the hospital can easily tell what medicine you have taken.
3. HOW TO TAKE GABAPENTIN Always take Gabapentin 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. If you have the impression that the eect of Gabapentin 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 Gabapentin normally except if you have problems with your kidneys. Your doctor may prescribe a dierent dosing schedule and/or dose if you have problems with your kidneys.
Always swallow the capsules whole with plenty of water. Continue taking Gabapentin until your doctor tells you to stop. Peripheral Neuropathic Pain: Take the number of capsules 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.
Epilepsy: Adults and adolescents: Take the number of capsules 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 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 childs weight. The treatment is
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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.