Patient leaflet - Gabapentin Rivipharm 800 mg film-coated tablets

1. WHAT GABAPENTIN TABLETS ARE AND WHAT THEY ARE USED FOR

Gabapentin Tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). It contains gabapentin which belongs to a class of medicines called gabapentinoids. This medicine has been prescribed to you and should not be given to anyone else.

Gabapentin is used to treat has been prescribed to you for:

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 Tablets to help treat epilepsy when your current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gabapentin Tablets in addition to the current treatment unless told otherwise. Gabapentin 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.

Gabapentin can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. 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. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN TABLETS

Do not take Gabapentin 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 prescriber before taking this medicine if you:

are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to take more gabapentin tablets 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.

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.

Talk to your doctor or pharmacist before taking Gabapentin tablets:

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 Tablets.

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. 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.

Dependence

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

If you notice any of the following signs whilst taking Gabapentin 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 ‘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 tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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 tablets. In addition, combination of Gabapentin tablets with opioids may cause symptoms like sleepiness, sedation, decrease in breathing, or death.

Antiacids for indigestion.

If Gabapentin Tablets and antiacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Tablets from the stomach may be reduced.

It is therefore recommended that Gabapentin Tablets are taken at the earliest two hours after taking an antacid

Gabapentin Tablets

are not expected to interact with other anti-epileptic 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 Tablets with food -Gabapentin 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 breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentin 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.

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).

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

Breastfeeding

Gabapentin, the active substance of Gabapentin 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 Tablets.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin 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 TABLETS

Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. 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.

Always take Gabapentin Tablets 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. Do not take more medicine than prescribed.

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 of body weight 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 Tablets are 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 usual 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 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 tablets is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin tablets is for oral use. Always swallow the tablets with plenty of water. The tablet can be divided into equal halves.

Continue taking Gabapentin Tablets until your doctor tells you to stop.

If you take more Gabapentin 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 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 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 Tablets

Do not suddenly stop taking Gabapentin Tablets or reduce your dose. If you want to stop taking Gabapentin Tablets or reduce your dose, discuss this with your doctor first. They will tell you how to do this. 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 Tablets 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 Tablets or reducing your dose. If you experience withdrawal effects, you should contact your doctor.

If you stop taking Gabapentin Tablets - Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber 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.

Withdrawal symptoms such as: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gabapentin Tablets can cause side effects, although not everybody gets them:

Stop using Gabapentin 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 9 skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnsonsyndrome, 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:

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 hospitalized or to stop gabapentin. Call your doctor right away if you have any of the following symptoms:
- skin rash
- hives
- fever
- swollen glands that do not go away
- swelling of your lip 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
Feeling drowsy, dizziness, lack of coordination
Feeling tired, fever

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

Pneumonia, respiratory infection, 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, increase, 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 reaction 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
Difficulty with thinking • Increase in blood glucose levels (most often observed in patients with diabetes)

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 (reported since introduction to the market):

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).
Worsening of myasthenia gravis (a disease causing muscle weakness)

Unknown frequency: dependence and addiction (see section “How do I know if I am tolerant or addicted?”)

Drug Withdrawal

When you stop taking Gabapentin Tablets, 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 <product name>, 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.

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 TABLETS

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store Gabapentin Tablets above 25°C. Store in the original package in order to protect from moisture

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. CONTENT OF THE PACK AND OTHER INFORMATION What Gabapentin Tablets contain

The active substance is gabapentin . Each film-coated tablet contains either 600 mg or 800 mg gabapentin.

The other ingredients in Gabapentin Tablets are:

Tablet core: Poloxamer type 407, Copovidone, Sodium Starch Glycolate type A, Hydrogenated vegetable oil, Talc, Colloidal silica anhydrous.

Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc.

What Gabapentin Tablets look like and contents of the pack

Gabapentin 600 mg film-coated tablets are white oval film-coated tablets embossed with '600', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50,

84, 90, 100, 200, 500 tablets.

Not all pack sizes may be marketed.

Gabapentin 800 mg film-coated tablets are white oval film-coated tablets embossed with '800', supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 45, 50,

84, 90, 100, 200, 500tablets.