• 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.

1. What Gabapentin Oral Solution is and what it is used for
2. What you need to know before you take Gabapentin Oral Solution
3. How to take Gabapentin Oral Solution
4. Possible side effects
5. How to store Gabapentin Oral Solution
6. Contents of the pack and other information

• if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Gabapentin Oral Solution:

• if you suffer from kidney problems your doctor may prescribe a different dosing schedule.
• if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Gabapentin Oral Solution. Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience.
• if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen.

Dependence

Some people may become dependent on Gabapentin Oral Solution (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Oral Solution (see section 3, “How to take Gabapentin Oral Solution” and “If you stop taking Gabapentin Oral Solution”). If you have concerns that you may become dependent on Gabapentin Oral Solution, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Gabapentin Oral Solution, it could be a sign that you have become dependent.

• You feel you need to take the medicine for longer than advised by your prescriber
• You feel you need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
• 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.

• 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).
• 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 and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• If you experience any of the following signs or symptoms, please contact your doctor immediately:
  Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature because it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discolouration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased).
• If you have thoughts of harming or killing yourself: A small number of people being treated with antiepileptics such as this medicine have had suicidal thoughts. If at any time you have these thoughts, contact your doctor immediately.

• If you require a urine test tell your doctor or hospital you are taking this medicine because it may affect some laboratory test results.

Gabapentin Oral Solution is not recommended for use in children under 6 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because gabapentin can affect the way some other medicines work. Also some other medicines can affect the way gabapentin works.

In particular you must 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 because they can increase the effect of gabapentin and may cause symptoms like sleepiness, sedation, decrease in breathing, or death.
• Antacids for indigestion because if the antacids contain aluminium or magnesium and are taken at the same time, absorption of gabapentin from the stomach may be reduced making it less effective. It is therefore recommended that Gabapentin Oral Solution is taken at least two hours after taking an antacid.

Gabapentin Oral Solution does not normally affect:

• the oral contraceptive pill.

Gabapentin Oral Solution can be taken with or without food.

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 Oral Solution 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.

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).

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 developing baby, particularly when more than one medicine to control seizures is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor.

• Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking this medicine.
• Do not suddenly stop taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.

Breast-feeding

The active ingredient in this medicine, gabapentin, is passed into breast milk. Breast-feeding is not recommended while you are taking Gabapentin Oral Solution because the effect on the baby is unknown.

Fertility

There is no effect on fertility in animal studies.

• Gabapentin Oral Solution can make you feel dizzy, drowsy and tired, especially when you start this treatment or if your dose is increased.
• You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medicine affects your ability to carry out these activities safely.
• If you experience side effects which may affect your ability to do these activities safely, then do not drive or operate machinery until the effects have completely disappeared.

• parahydroxybenzoates which may cause allergic reactions (possibly delayed)
• small amounts of ethanol (alcohol), less than 100mg per ml.

Adults and adolescents:

• Your doctor will usually build up your dose gradually.
• The starting dose will generally be between 6ml (300mg) and 18ml (900mg) each day.
• Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 72ml (3600mg) 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 to 12 years old:

• The dose to be given to your child will be decided by your doctor as it is calculated using 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 25–35mg per kg of body weight per day. It is usually given in 3 separate doses, usually once in the morning, once in the afternoon and once in the evening.

Adults:

• Your doctor will usually build up your dose gradually.
• The starting dose will generally be between 6ml (300mg) and 18ml (900mg) each day.
• Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 72ml (3600mg) 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 Oral Solution 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 think that this medicine is either not working as well as it should be or the effect is too strong talk to your doctor or pharmacist as soon as possible.

• This medicine is for oral use.
• Once the bottle is opened, use within 1 month.
• Your pack contains a plastic syringe to measure the right amount of liquid prescribed for you. The numbers up to 10 on the side show how many millilitres (mls) of liquid you have inside the syringe.

1. Open the bottle, press the cap and turn it anticlockwise (figure 1).
2. Insert the syringe adaptor into the bottle neck (figure 2).
3. Take the syringe and put it in the adaptor opening (figure 2).
4. Turn the bottle upside down (figure 3).
5. Fill the syringe with a small amount of solution by pulling the piston down (figure 4A).
Then push the piston upward in order to remove any possible bubbles (figure 4B).
Finally, pull the piston down to the graduation mark corresponding to the quantity in ml prescribed by your doctor (figure 4C).
6. Turn the bottle the right way up.
7. Remove the syringe from the adaptor. Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine.
8. Repeat steps 3 to 7 if necessary to take the full dose prescribed by your doctor.
9. Wash the syringe with water and let it dry before you use it again.
10. Close the bottle with the plastic screw cap.

This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. If you want to know more, there is information in the Summary of Product Characteristics (SmPC). Ask your doctor, pharmacist or nurse about this.

Only use polyurethane NG or PEG tubes.

1. Ensure the tube is clear before administering the medicine.
2. Flush the tube with 10ml of boiled cooled water.
3. Administer the medicine into the tube with a suitable measuring device.
4. Immediately, flush the tube again, twice, with 10ml of boiled cooled water.

• Higher than recommended doses may result in an increase in side effects including:
  • loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea.
• Seek medical advice or go to the nearest hospital emergency unit immediately if you take more Gabapentin Oral Solution than your doctor has prescribed. If possible take this medicine pack with you to show them what 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 Oral Solution. If you want to stop taking Gabapentin Oral Solution, 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 Oral Solution, 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 Oral Solution. If you experience withdrawal effects, you should contact your doctor.

• 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. 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 contains 50mg gabapentin.
• The other ingredients are:
  • Sodium methyl parahydroxybenzoate (E219)
  • Sodium propyl parahydroxybenzoate (E217)
  • Propylene glycol
  • Sodium carmellose (Blanose 7MF)
  • Acesulfame potassium
  • Orange flavour (contains ethanol (alcohol))
  • Hydrochloric acid solution 17%
  • Purified water.

• Gabapentin Oral Solution is a clear colourless liquid with an orange flavour supplied in a 150ml amber glass bottle with a child resistant cap.
• Each carton includes a CE marked, 10ml graduated oral dosing syringe and a “press-in” syringe/bottle adaptor.