Patient Leaflet Updated 26-Feb-2021 | Glenmark Pharmaceuticals Europe Ltd
Gabapentin Glenmark 50 mg/ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gabapentin Glenmark 50 mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
What is in this leaflet:
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
1. WHAT GABAPENTIN ORAL SOLUTION IS AND WHAT IT IS USED FOR
Gabapentin Glenmark 50 mg/ml Oral Solution (referred to in this leaflet as Gabapentin Oral Solution) contains the active ingredient gabapentin. It belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).
For peripheral neuropathic pain (long lasting pain caused by damage to the nerves).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN ORAL SOLUTION
Do not take Gabapentin Oral Solution if:
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin:
Important Information about potentially serious reactions
Other medicines and Gabapentin:
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 recently taken any medicines for convulsions (fits), sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
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 the hospital staff that you are taking Gabapentin.
Medicines containing opioids such as morphine
Tell your doctor or pharmacist if you are taking medicines containing opioids (such as morphine) for treating pain. This is because morphine may increase the effect of Gabapentin. You may also have symptoms such as sleepiness and/or decrease in breathing.
Antacids for indigestion
If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, the 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.
Gabapentin with food and drink
Gabapentin can be taken with or without food.
Pregnancy, breast-feeding and fertility
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin.
Gabapentin 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.
There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medicines used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medicine is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medicine during pregnancy and only under the advice of your doctor.
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.
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.
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin may cause dizziness, drowsiness and tiredness. You should not drive, operate machinery or take part in other potentially hazardous activities until you know whether this medicine affects you.
Gabapentin Oral Solution contains
3. HOW TO TAKE GABAPENTIN ORAL SOLUTION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you. This will depend on how well your body responds to this medicine.
How and when to take Gabapentin Oral Solution
Gabapentin is for oral use and should be taken with plenty of water.
It is usually given in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
Continue taking Gabapentin until your doctor tells you to stop.
Adults and adolescents
The starting dose will generally be between 300 mg and 900 mg each day (6 to 18 ml). Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day (72 ml)
Children aged 6 years old 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 per day. Gabapentin is not recommended for use in children under 6 years old.
Peripheral neuropathic pain:
The starting dose will generally be between 300 mg and 900 mg each day (6 to 18 ml).
Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day (72 ml).
If you have kidney problems or are receiving haemodialysis
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 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 the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Measuring your dose using the oral syringe provided
Your pack contains a plastic oral syringe to measure the right amount of liquid prescribed for you.
The numbers up the side show how many millilitres (ml) 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).
6. Push the piston upward in order to remove any possible bubbles (figure 4B).
7. Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 4C).
8. Turn the bottle the right way up.
9. 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.
10. Wash the syringe with water and let it dry before you use it again.
11. Close the bottle with the plastic screw cap.
If you take more Gabapentin than you should
If you forget to take Gabapentin
If you stop taking Gabapentin
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may happen with this medicine:
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
Other side effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
After marketing Gabapentin the following side effects have been reported:
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 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.
5. HOW TO STORE GABAPENTIN ORAL SOLUTION
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Gabapentin Oral Solution contains:
What Gabapentin Oral Solution looks like and contents of the pack
Gabapentin is a clear, colourless oral solution. It comes in an amber coloured glass bottle as well as in an amber coloured polyethylene terephthalate bottle holding 150 ml of solution.
In the pack there is also a 10 ml oral syringe, with markings at every 1ml and intermediate marks at every 0.5 ml.
Marketing Authorisation Holder
This leaflet was last revised in 07/2020
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