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The product code(s) for this leaflet is: PL 39307/0068.
Gabapentin Thame 50mg/ml Oral Solution
Gabapentin Thame 50 mg/ml Oral Solution
gabapentin
1. What Gabapentin Thame is and what it is used for
2. What you need to know before you take Gabapentin Thame
3. How to take Gabapentin Thame
4. Possible side effects
5. How to store Gabapentin Thame
6. Contents of the pack and other information
Gabapentin Thame contains the active substance gabapentin which belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).
You must talk to a doctor if you do not feel better or if you feel worse.
Talk to your doctor or pharmacist before taking Gabapentin Thame:
Dependence
Some people may become dependent on Gabapentin Thame (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Thame (see section 3, “How to take Gabapentin Thame” and “If you stop taking Gabapentin Thame”). If you have concerns that you may become dependent on Gabapentin Thame, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Gabapentin Thame, it could be a sign that you have become dependent.
If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.
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.
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using Gabapentin Thame and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Medicines containing opioids such as morphine
If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opioids may increase the effect of Gabapentin Thame. In addition, combination of Gabapentin Thame with opioids may cause sleepiness, sedation, decrease in breathing, or death.
Antacids for indigestion
If Gabapentin Thame and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Thame from the stomach may be reduced. It is therefore recommended that Gabapentin Thame is taken at the earliest two hours after taking an antacid.
Gabapentin Thame
Gabapentin Thame can be taken with or without food.
Pregnancy
Gabapentin Thame can be used during the first trimester of pregnancy if needed.
If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away.
If you have become pregnant and you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.
In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.
If used during pregnancy, Gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when Gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain).
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Thame. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.
Breast-feeding
Gabapentin is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Thame.
Fertility
There is no effect on fertility in animal studies.
Gabapentin Thame may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.
Your doctor will determine what dose is appropriate for you.
Adults and adolescents:
Your doctor will usually build up your dose gradually. The starting dose will generally be between 6 ml (300 mg) and 18 ml (900 mg) each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 72 ml (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 0.5 ml-0.7 ml (25-35 mg) per kg of body weight per day. It is usually given in 3 separate doses each day, usually once in the morning, once in the afternoon and once in the evening.
Gabapentin Thame is not recommended for use in children below 6 years of age.
Adults:
Your doctor will usually build up your dose gradually. The starting dose will generally be between 6 ml (300 mg) and 18 ml (900 mg) each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 72 ml (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.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.
If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin Thame 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 the impression that the effect of Gabapentin Thame is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
This medicinal product must be taken orally.
Use the measuring syringe provided in the pack to deliver the required dose.
For higher dose, you may require to repeat the below steps. The examples for number of withdrawals required for higher doses are provided below:
For a 300 mg dose, the dose would be 6 ml and the volume to be withdrawn with a syringe would be 6 ml in one withdrawal.
For a 900 mg dose, the dose would be 18 ml and the volume to be withdrawn with a syringe would be one full syringe plus 8 ml in a second withdrawal
For a 1200 mg three times a day dose (3600 mg as maximum daily dose), the dose would be 24 ml three times a day (72 ml as a maximum daily dose) and the volume to be withdrawn with a syringe would be two full syringes plus 4 ml in a third withdrawal (to be taken three times a day).
a) Open the bottle: press the cap and turn it anticlockwise (figure 1).
b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).
c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient’s mouth to avoid a choking hazard. Leave the syringe adaptor in place after first use. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).
Higher than recommended doses may result in an increase in side 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 if you take more Gabapentin Thame than your doctor prescribed. Take along any leftover medicine with you, as well as the container and the label so that the hospital can easily tell what medicine you have taken.
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.
Do not suddenly stop taking Gabapentin Thame. If you want to stop taking Gabapentin Thame, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week. After stopping a short or long-term treatment with Gabapentin Thame, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin Thame. If you experience withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Thame.
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)
Common: (may affect up to 1 in 10 people)
Uncommon: (may affect up to 1 in 100 people)
Rare: (may affect up to 1 in 1,000 people)
After stopping a short or long-term treatment with Gabapentin Thame, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Gabapentin Thame”).
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.
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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.
The active substance is gabapentin.
Each ml of oral solution contains 50 mg gabapentin.
The other ingredients are acesulfame potassium (E950), saccharin sodium (E954), propylene glycol (E1520), methyl parahydroxybenozate (E218), ethyl parahydroxybenzoate (E214), carmellose sodium (E466) and purified water.
Gabapentin Thame is a clear, colourless oral solution supplied in an amber glass bottle fitted with a child-resistant plastic cap and a 10 ml oral syringe with 0.5 ml graduation and a bottle adaptor for syringe.
Gabapentin Thame is supplied in bottles containing 150 ml of solution.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
MT, IE and UK (NI): Gabapentin Thame 50 mg/ml Oral Solution
If this leaflet is hard to see or read, please call +44(0) 208 515 3700 for help.
This leaflet was last revised in 06/2025.
PIL/UK/MFG007/07/v11