Patient leaflet - Gabapentin Milpharm 800 mg film-coated tablets

1. What Gabapentin Milpharm Tablets is and what it is used for

Gabapentin Milpharm Tablets belongs 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 Milpharm Tablets is gabapentin.

Gabapentin Milpharm is 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 Milpharm Tablets 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 Milpharm Tablets in addition to the current treatment unless told otherwise. Gabapentin Milpharm 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 Milpharm Tablets

Do not take Gabapentin Milpharm 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 Milpharm

if you suffer from kidney problems your doctor may prescribe
a different dosing schedule;
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.
- If you have myasthenia gravis (a disease causing muscle
weakness) because this medicine may make your symptoms worse

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 Milpharm.

Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. Talk to your doctor if you have a history of abuse or dependence. Dependence

Some people may become dependent on Gabapentin Milpharm (a need to keep taking the medicine).

They may have withdrawal effects when they stop using Gabapentin Milpharm or reduce the dose (see section 3, “How to take Gabapentin Milpharm” and “If you stop taking Gabapentin Milpharm”). If you have concerns that you may become dependent on Gabapentin Milpharm, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Gabapentin Milpharm, 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.

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.

Important information about potentially serious reactions

A small number of people taking Gabapentin Milpharm Tablets get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Gabapentin Milpharm Tablets.

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.

Other medicines and Gabapentin Milpharm 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 Milpharm Tablets. In addition, combination of Gabapentin Milpharm with opioids may cause sleepiness, sedation, decrease in breathing, or death.

Antacids for indigestion

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

Gabapentin Milpharm 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 Milpharm Tablets with food, drink and alcohol

Gabapentin Milpharm 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.

Pregnancy

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

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. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Milpharm Tablets. 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.

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).

Breast feeding

Gabapentin, the active substance of Gabapentin Milpharm 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 Milpharm Tablets.

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.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin Milpharm 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 Milpharm Tablets

Always take this medicine exactly as your doctor, 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 per kg 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 Milpharm 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.

N09088

1. 05-APR-2024 (Vikas) - FR
2. 14-NOV-2025 (V Rohan) - FR1
3. 24-NOV-2025 (Dipali) - RR1
4. 29-JAN-2026 (Pratiksha) - FR2

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Team Leader

Initiator

Design Agency

APL_LN 2635

Date - Designer - Run:

Additional Information:

Customer / Country Reason of Issue

No. of Colours : 1

Gabapentin Milpharm

600 mg and 800 mg Leaflet N09088 29.01.2026 & 02:39 PM

195 x 480 mm

Narendar

Ramesh

Sign / Date

If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin Milpharm 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.

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

Method of administration

Gabapentin Milpharm Tablets is for oral use. Always swallow the tablets with plenty of water.

The tablet can be divided into equal doses. Continue taking Gabapentin Milpharm until your doctor tells you to stop.

If you take more Gabapentin Milpharm 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 Milpharm than your doctor prescribed. Take along any capsules or 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 Milpharm 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 Milpharm Tablets

Do not suddenly stop taking Gabapentin Milpharm or reduce your dose. If you want to stop taking Gabapentin Milpharm or reduce your dose, 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 or your dose is reduced, a short or long-term treatment with Gabapentin Milpharm or after reducing your dose, 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 Milpharm or reducing your dose. 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 Milpharm 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 Milpharm Tablets 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 hospitalized or to stop Gabapentin Milpharm Tablets. 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 Milpharm Tablets.

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.
Feeling drowsy, dizziness, lack of coordination.
Feeling tired, fever.

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

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
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.
Blurred vision, double vision.
Vertigo.
High blood pressure, flushing or dilation of blood vessels.
Difficulty breathing, bronchitis, sore throat, cough, 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.
- Difficulty swallowing
- Swelling that may involve the face, trunk and limbs.
- Abnormal blood test results suggesting problems with the liver.
- Fall
- Mental impairment
- Increase in blood glucose levels (most often observed in patients with diabetes)

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

Loss of consciousness
Decrease in blood glucose levels (most often observed in patients with diabetes)
Trouble breathing, shallow breaths (respiratory depression)

After marketing Gabapentin the following side effects have been reported:

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

Decreased platelets (blood clotting cells).
Suicidal thoughts, hallucinations.
Problems with abnormal movements such as writhing, jerking movements and stiffness.
Ringing in the ears.
Yellowing of the skin and eyes (jaundice), inflammation of the liver.
Acute kidney failure, incontinence.
Increased breast tissue, breast enlargement. Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
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)
Becoming dependent on Gabapentin Milpharm (‘drug dependence’)
Worsening of myasthenia gravis (a disease causing muscle weakness)

After stopping a short or long-term treatment with Gabapentin Milpharm or after reducing your dose, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Gabapentin Milpharm”).

Reporting of side effects

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 Yellow Card Scheme,Website: 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 Milpharm Tablets

Keep this medicine out of the sight and reach of children. 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 the month.

Store below 25°C.

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

The active substance is gabapentin.
Each film-coated tablet contains 600 mg gabapentin. Each film-coated tablet contains 800 mg gabapentin.
The other ingredients in are: Maize starch, crospovidone
(Type A), copovidone (VA 64), microcrystalline cellulose (KG-1000), microcrystalline cellulose (PH-102), magnesium stearate
coating material: Hydroxypropyl cellulose, talc

What Gabapentin Milpharm Tablets looks like and contents of the pack

Film-coated tablet

Gabapentin Milpharm 600 mg tablets are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘24’ on either side of the break line on one side and plain on other side.

Gabapentin Milpharm 800 mg tablets are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘25’ on either side of the break line on one side and plain on other side.

Gabapentin Milpharm film-coated tablets are available in Polyamide/Aluminium/PVC – Aluminium foil blister pack: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets

HDPE container: 20 and 500 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder

Milpharm Limited

1 Roundwood Avenue

Stockley Park, Uxbridge

UB11 1AF

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta