Gabapentin 800mg Film-Coated Tablets
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Gabapentin Rivopharm 600 mg film-coated Tablets Gabapentin Rivopharm 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.
- Ifyou 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 ifyou 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
- ifyou are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin Tablets
Take special care with Gabapentin Tablets
- ifyou suffer from kidney problems
- ifyou are on haemodialysis, tell your doctor ifyou develop muscle pain and/or weakness
- ifyou 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.
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.
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 ifyou 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.
Ifyou 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, tne 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 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 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 is 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:
Ifyou are an elderly patient (over 65 years of age), you should take the normal doseofGabapentinTablets unless you have problems with your kidneys.
If you have kidney problems or are receiving dialysis
Your doctor may prescribe a different dosing schedule and/or dose ifyou have problems with your kidneys or are undergoing dialysis.
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, feeTing 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
• Inflammation of the pancreas
• Inflammation 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 fluctuations 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
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 25°C. 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 floor, 28 Kingsway, London WC2B 6JR, UK
Manufacturer
SynerLAB - Laboratoires BTT
Zone Industrielle de Krafft 67150 Erstein, FRANCE
This leaflet was last approved in 06/2014
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