Gabapentin Zentiva 400 mg capsules – patient leaflet, side effects, dosage

1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR

This medicine is called Gabapentin Zentiva (called gabapentin throughout this leaflet) and it contains the active substance gabapentin which belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). Gabapentin 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 (aged 6 years of age and older) will prescribe gabapentin to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child (aged 6 years of age and older) should take gabapentin in addition to the current treatment unless told otherwise. Gabapentin 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

Do not take Gabapentin

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

Talk to your doctor or pharmacist before taking gabapentin:

• 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 or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on gabapentin.

Dependence

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

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

Cases of abuse and dependence have been reported for gabapentin. 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, contact your doctor immediately.

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 ‘Tell your doctor straight away’. Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature, 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

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, 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), tell your doctor or pharmacist as opioids may increase the effect of gabapentin. In addition, the combination of gabapentin with opioids may cause symptoms like sleepiness, sedation, a decrease in breathing or death.

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 is not expected to interact with other drugs against epilepsy or your oral contraceptive pill.

Gabapentin may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking. Gabapentin with food

Gabapentin 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 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. 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.

Breast-feeding

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.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin 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 medicine affects your ability to perform these activities. Gabapentin Capsules contains lactose.

Gabapentin capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE GABAPENTIN

Always take this medicine exactly as your doctor 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.

If you take gabapentin to treat epilepsy the recommended dose is

Adults and adolescents

Take the number of capsules as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300mg and 900mg each day.

Thereafter, the dose may be increased progressively up to a maximum of 3600mg each day. Your doctor will tell you to take the dose in 3 divided 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 25-35mg/kg/day.

It is usually given in 3 divided doses, by taking the capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin is not recommended for use in children below 6 years of age.

If you take gabapentin to relieve peripheral neuropathic pain the recommended dose is

Adults

Take the number of capsules as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300mg and 900mg each day.

Thereafter, the dose may be increased progressively up to a maximum of 3600mg each day. Your doctor will tell you to take the dose in 3 divided 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. Method of administration

Gabapentin is for oral use. Always swallow the capsules with plenty of water.

Continue taking gabapentin until your doctor tells you to stop. You should not stop taking this medicine without medical advice. If you take more gabapentin 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 than your doctor prescribed. Take along any capsules 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

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

Do not suddenly stop taking gabapentin. If you want to stop taking gabapentin, 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, 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. 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 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). Stop taking this medicine and see a doctor straight away if you experience any of the following symptoms 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. These may be symptoms of acute pancreatitis (an inflamed pancreas).
• breathing problems, if severe you may need emergency and intensive care to continue breathing normally

• serious or life-threatening allergic reactions that may affect your skin (a skin rash) or other parts of your body such as your liver or blood cells . You may or may not have a skin rash when you get this type of reaction. You may need to be hospitalized; contact your doctor immediately if you have the following:

  • skin rashes
  • fever
  • hives
  • 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, dizzy, lack of coordination
• Feeling tired, fever

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

• Pneumonia, respiratory infections, urinary tract infections, inflammation of the ear or other infections
• Low white blood cell counts
• Anorexia, increase in appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, strange or unusual thoughts
• Convulsions, jerky movements, difficulty speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movements, 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 erections (impotence),
• Swelling in the legs and arms, difficulty in walking, weakness, pain, feeling unwell, flu-like symptoms
• Decrease in white blood cells, increase in weight
• Accidental injury, fractures, abrasions

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

• Decreased movement
• Falls
• Mental impairment
• Racing heartbeat
• Swelling that may involve the face, body and limbs
• Abnormal blood test results suggesting problems with the liver
• Increase in blood glucose levels (most often observed in patients with diabetes)
• Agitation (a state of chronic restlessness and unintentional and purposeless motions)
• Difficulty swallowing
• Allergic reaction such as hives

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 breathing (respiratory depression)

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

• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• Acute kidney failure, incontinence (leakage of urine which you cannot control)
• Yellowing of the skin and eyes (jaundice), inflammation of the liver
• Suicidal thoughts
• Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
• Increased breast tissue, breast enlargement
• Adverse events following the sudden stopping of gabapentin (anxiety, difficulty in sleeping, feeling sick, pain, sweating), chest pain
• Breakdown of muscle fibers (rhabdomyolysis)
• Low blood sodium level (hyponatraemia)
• Change in blood test results (creatine phosphokinase increased)
• Problems with sexual function including inability to achieve a sexual climax, delayed ejaculation
• Becoming dependent on gabapentin (‘drug dependence’)

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

Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly. 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 the Yellow Car 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

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

Do not store above 25°C.

Do not use these capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gabapentin Capsules contain:

The active substance is gabapentin. Each capsule contains either: 100mg, 300mg or 400mg of gabapentin. The other ingredients are:

Gabapentin 100mg Capsules: lactose monohydrate, maize starch, talc, titanium oxide (E171) and gelatin. Gabapentin 300mg Capsules: lactose monohydrate, maize starch, talc, titanium oxide (E171), yellow iron dioxide (E172) and gelatin. Gabapentin 400mg Capsules: lactose monohydrate, maize starch, talc, titanium dioxide (E171), yellow iron dioxide (E172), red iron oxide (E172) and gelatin.

The printing ink used on the capsule contains: shellac (E104), titanium (E171) and FD&C Blue 1/Brilliant blue FCF Lake (E133). What Gabapentin Capsules looks like and contents of the pack:

The 100mg Capsules are white, hard capsules marked S154 on one side.

The 300mg Capsules are yellow, hard capsules marked S155 on one side.

The 400mg Capsules are orange-yellow, hard capsules marked S156 on one side.

Pack size: 100 capsules.

Marketing Authorisation Holder

Zentiva Pharma UK Limited,

12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Manufacturers

Zentiva Pharma UK Limited,

Office 136-152, Austen House, Station View Units A-J, Guildford, GU1 4AR, United Kingdom

or

Zentiva Pharma UK Limited,

First Floor, Andrews House, College Road, Guildford, GU1 4QB, United Kingdom

This leaflet was last revised in October 2023 XXXXXXXXXX