Gabapentin 600 mg film-coated tablets

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

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

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.
• Before taking this medicine, tell your doctor if you have ever abused, addicted or been dependent on alcohol, prescription medicines or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.; it may mean you have a greater risk of becoming dependent on Gabapentin Milpharm.
• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• if you feel you need to take more of Gabapentin Milpharm to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
• If you have myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Gabapentin should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentin, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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.

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.

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 Tablets 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 can be taken with or without food.

• 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.

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.

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.

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 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.

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.

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 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 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, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. If your treatment is stopped or your dose is reduced, it should be done gradually over a minimum of 1 week. 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. These effects can include seizures, anxiety, trouble sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling anxious, flu-like symptoms, convulsions, nervousness, thoughts of harming or killing yourself, 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.

• 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)

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)
• dependence and addiction (see section “How do I know if I am tolerant or addicted?”)
• Worsening of myasthenia gravis (a disease causing muscle weakness)

Drug Withdrawal

When you stop taking Gabapentin Milpharm , you may experience drug withdrawal symptoms, which include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

How do I know if I am tolerant or addicted?

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

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

After stopping a short or long-term treatment with Gabapentin 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”).

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.

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

or