Patient leaflet - Gabapentin Accord 800 mg film-coated tablets

1. What Gabapentin Film-coated tablets are and what they are used for

Gabapentin Film-coated tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

The active substance in Gabapentin Film-coated tablets is gabapentin.

Gabapentin Film-coated tablets are 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). The doctor treating you or your child 6 years of age and older will prescribe Gabapentin Film-coated tablets for you to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gabapentin Film-coated tablets in addition to the current treatment unless told otherwise. Gabapentin Film-coated tablets can also be used on its own to treat adults and children over 12 years of age.
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. What you need to know before you take Gabapentin Film-coated tablets

Do not take Gabapentin Film-coated tablets

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentin Film-coated tablets:

if you suffer from kidney problems your doctor may prescribe a different dosing schedule
before taking this medicine, tell your doctor 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 Film-coated tablets.
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).
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 Film-coated tablets (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Film-coated tablets (see section 3, “How to take Gabapentin Film-coated tablets” and “If you stop taking Gabapentin Film-coated tablets”). If you have concerns that you may become dependent on Gabapentin Film-coated tablets, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Gabapentin Film-coated tablets, 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.

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.

Important information about potentially serious reactions

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.

Read the description of these symptoms in section 4 of this leaflet under “Stop using Gabapentin Film-coated tablets and seek medical attention immediately if you notice any of the following symptoms”

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.

Other medicines and Gabapentin Film-coated tablets

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 Film-coated tablets. In addition, combination of Gabapentin film-coated tablets with opioids may cause sleepiness, sedation, decrease in breathing, or death.

Antacids for indigestion

If Gabapentin Film-coated tablets and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Film-coated tablets from the stomach may be reduced. It is therefore recommended that Gabapentin Film-coated tablets is taken at the earliest two hours after taking an antacid.

Gabapentin Film-coated tablets:

is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.

Gabapentin Film-coated tablets with food

Gabapentin Film-coated tablets can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby
If you are planning to become pregnant you should discuss your treatment with your doctor as early as possible before you become pregnant
You should not stop your treatment without discussing this with your doctor.
If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine.

Pregnancy

Gabapentin Film-coated tablets 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.

There have been very few studies specifically looking at the use of gabapentin in pregnant women. More research is needed to better understand the safety of use of gabapentin during pregnancy and whether it is associated with an increased risk of harm to the unborn child.

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).

Some medicines used to treat epilepsy have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy.

Breast-feeding

Gabapentin, the active substance of Gabapentin Film-coated 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 Film-coated tablets.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin Film-coated tablets 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.

3. How to take Gabapentin Film-coated tablets

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.

Epilepsy, the recommended dose is:

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, 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.

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/kg/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 Film-coated tablets is not recommended for use in children below 6 years of age.

Peripheral Neuropathic Pain, the recommended dose is:

Adults:

Take the number of tablets 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 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.

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 Film-coated tablets 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.

Package leaflet: Information for the user

Gabapentin Accord 600 mg Film-coated tablets Gabapentin Accord 800 mg Film-coated tablets

Gabapentin

		-
	Customer	Accord
	Description	Gabapentin 600 / 800 mg
	Market	UK
	Language	English
		190 x 600 mm (PIL)
		9
	Version No.	9 (Page 1 of 2) (IB/024)
	Date	29_07_17 (Gabapentin (ACC-UK)Type IB-PIL)

(6021969) Date : 08/02/2023, 20/02/2023, 24/02/2023, 01/03/2023, 06/03/2023, 30_03_2023, 31_03_2023, 01_04_2023, 01_05_2023 (1), 27_06_2023, (R) 20_01_2025 (1)

Back Side

If you have the impression that the effect of Gabapentin Film-coated tablets is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Film-coated tablets is for oral use. Always swallow the capsules or tablets with plenty of water.

Continue taking Gabapentin Film-coated tablets until your doctor tells you to stop.

If you take more Gabapentin Film-coated tablets than you should

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 Film-coated tablets than your doctor prescribed.

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 Film-coated 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 Film-coated tablets Do not suddenly stop taking Gabapentin Film-coated tablets. If you want to stop taking Gabapentin Film-coated tablets, 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 Film-coated tablets, 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 Film-coated tablets. 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Gabapentin Film-coated tablets and seek medical attention immediately if you notice any of the following symptoms:

reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor IMMEDIATELY if you experience any of the following symptoms after taking this medicine as they can be serious:

severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction)
persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
- Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalised or to stop gabapentin. Call your doctor right away if you have any of the following symptoms:
skin rash and redness and/or hair loss
hives
fever
swollen glands that do not go away
swelling of your lip, face and tongue
yellowing of your skin or of the whites of the eyes
unusual bruising or bleeding
severe fatigue or weakness
unexpected muscle pain
frequent infections

These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin.

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):

viral infection
dizziness
lack of coordination
feeling drowsy
feeling tired
fever.

Common (may affect up to 1 in 10 people):

convulsions
jerky movements
difficulty with speaking
loss of memory
tremor
difficulty sleeping
headache
sensitive skin
decreased sensation (numbness)
difficulty with coordination
unusual eye movement
increased, decreased or absent reflexes
pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections
low white blood cell counts
anorexia
increased appetite
anger towards others
confusion
mood changes
depression
anxiety
nervousness
difficulty with thinking
blurred vision, double vision
vertigo
high blood pressure
flushing or dilation of blood vessels
difficulty breathing, bronchitis, cough
sore throat
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
- difficulties with erection (impotence)
- swelling in the legs and arms
- difficulty with walking
- weakness, pain
- feeling 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 commonly.

Uncommon (may affect up to 1 in 100 people):

agitation (a state of chronic restlessness and unintentional and purposeless motions)
allergic reactions 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
mental impairment
fall
high blood sugar (most often observed in patients with diabetes)
difficulty swallowing.

Rare (may affect up to 1 in 1,000 people):

decrease in blood glucose levels (most often observed in patients with diabetes)
loss of consciousness
trouble breathing, shallow breaths (respiratory depression).

Not known (frequency cannot be estimated from the available data):

becoming dependent on Gabapentin Film-coated tablets (‘drug dependence’).

After marketing Gabapentin Film-coated tablets the following side-effects have been reported:

acute kidney failure, incontinence
inflammation of the liver, yellowing of the skin and eyes (jaundice),
suicidal thoughts, 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
breakdown of muscle fibers (rhabdomyolysis)
change in blood test results (creatine phosphokinase increased)
problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
low blood sodium level
anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment).

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 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.

5. How to store Gabapentin Film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Film-coated tablets contain:

The active substance is Gabapentin. Each film-coated tablet has either 600 mg or 800 mg Gabapentin.

The other ingredients are:

Core tablet:

Maize starch, Copovidone, Poloxamer 407, Hydroxypropyl cellulose (E463), Magnesium Stearate(E572)

Coating:

Hydroxypropyl cellulose (E463), talc

Printing ink composition

Propylene glycol, Shellac glaze, Iron oxide black (E172), Ammonium hydroxide

What Gabapentin Film-coated tablets look like and contents of the pack:

600 mg Tablets are available as Approximately 17.25 mm X 10.15 mm white to off-white, Oval shaped, film coated tablets imprinted G1 on one side with black ink and plain on other side.

800 mg Tablets are available as Approximately 19.5 mm x l0 mm white to off-white, Capsule shaped, film coated tablets imprinted G2 on one side with black ink and plain on other side.

Gabapentin Film-coated tablets are packed in PVC/PVdC -aluminum blister packs of 20, 30, 50, 60, 90, 100, 200 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Accord Healthcare Limited

Sage house, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited,