Patient leaflet - Gabapentin Dawa 400 mg capsules

1. What gabapentin is and what it is used for

This medicine has been prescribed for you for epilepsy or peripheral neuropathic pain (long lasting pain caused by damage to the nerves). It contains the 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.

Gabapentinoids 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.

Gabapentin is used to treat

Ÿ 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.

Ÿ 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

Ÿ 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: Ÿ have myasthenia gravis (a disease causing muscle weakness) because

this medicine may make your symptoms worse

Ÿ suﬀer from kidney problems your doctor may prescribe a diﬀerent dosing

schedule

Ÿ are on haemodialysis (to remove waste products because of kidney

failure), tell your doctor if you develop muscle pain and/ or weakness Ÿ 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)

Ÿ have nervous system disorders, respiratory disorders, or you are more

than 65 years old, your doctor may prescribe you a diﬀerent dosing regimen

Ÿ 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

Ÿ have previously suﬀered from withdrawal symptoms such as agitation,

anxiety, shaking or sweating, when you have stopped taking alcohol or drugs

Ÿ feel you need to take more of gabapentin 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.

Dependence

Some people may become dependant on gabapentin (a need to keep taking the medicine). They may have withdrawal eﬀects when they stop using gabapentin or reduce the dose (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.

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: Ÿ Gabapentinoids: 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.

Gabapentinoids 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 gabapentinoids may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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

A small number of people taking gabapentin 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.

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 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

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. In addition, the combination of gabapentin with opioids may cause symptoms like sleepiness, a 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 drugs 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

Ÿ 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

Ÿ If you are planning to become pregnant you should discuss your treatment with your doctor as early as possible before you become pregnant

Ÿ You should not stop your treatment without discussing this with your doctor.

Pregnancy

Gabapentin 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 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.

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 medication aﬀects your ability to perform these activities.

Gabapentin contains lactose

Gabapentin contains 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 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.

If you take gabapentin to treat epilepsy the recommended dose is

Your prescriber should have discussed with you how long the course of capsules 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.

Adults and adolescents

Take the number of capsules 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 capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.

FRONT 210 X 432 MM 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 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 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 is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

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 or reduce your dose. If you want to stop taking gabapentin 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 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 or reducing your dose. If you experience withdrawal eﬀects, you should contact your doctor.

4. Possible side eﬀects

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

Stop taking this medicine and see a doctor straight away if you experience any of the following symptoms as they can be serious:

Ÿ 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)

Ÿ persistent stomach pain, feeling sick and being sick as these may be

symptoms of acute pancreatitis (an inﬂamed pancreas) Ÿ breathing problems, which if severe you may need emergency and

intensive care to continue breathing normally

Ÿ 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:

Ÿ skin rash

Ÿ hives

Ÿ fever

Ÿ swollen glands that do not go away

Ÿ swelling of your lip and tongue

Ÿ yellowing of your skin or of the whites of the eyes

Ÿ unusual bruising or bleeding

Ÿ severe fatigue or weakness

Ÿ unexpected muscle pain

Ÿ 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.

Ÿ If you are on haemodialysis, tell your doctor if you develop muscle pain

and/or weakness.

After marketing gabapentin the following side eﬀects have been reported: Very common: (may aﬀect more than 1 in 10 people)

Ÿ Viral infection

Ÿ Feeling drowsy, dizziness, lack of coordination

Ÿ Feeling tired, fever

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

Ÿ Pneumonia, respiratory infections, urinary tract infection, inﬂammation of

the ear or other infections

Ÿ Low white blood cell counts

Ÿ Anorexia, increased appetite

Ÿ Anger towards others, confusion, mood changes, depression, anxiety,

nervousness, diﬃculty with thinking

Ÿ 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

Ÿ Blurred vision, double vision

Ÿ Vertigo

Ÿ High blood pressure, ﬂushing or dilation of blood vessels Ÿ Diﬃculty breathing, bronchitis, sore throat, cough, dry nose Ÿ Vomiting (being sick), nausea (feeling sick), problems with teeth,

inﬂamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, ﬂatulence

Ÿ Facial swelling, bruises, rash, itch, acne

Ÿ Joint pain, muscle pain, back pain, twitching

Ÿ Diﬃculties with erection (impotence)

Ÿ Swelling in the legs and arms, diﬃculty with walking, weakness, pain,

feeling unwell, ﬂu-like symptoms

Ÿ Decrease in white blood cells, increase in weight

Ÿ Accidental injury, fracture, abrasion

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

Ÿ Agitation (a state of chronic restlessness and unintentional and purposeless motions)

Ÿ Allergic reaction such as hives

Ÿ Decreased movement

Ÿ Racing heartbeat

Ÿ Swelling that may involve the face, trunk and limbs

Ÿ Abnormal blood test results suggesting problems with the liver Ÿ Mental impairment

Ÿ Fall

Ÿ Increase in blood glucose levels (most often observed in patients with diabetes)

Ÿ Diﬃculty swallowing

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

Ÿ Decrease in blood glucose levels (most often observed in patients with diabetes)

Ÿ Loss of consciousness

Ÿ Trouble breathing, shallow breaths (respiratory depression)

Not known (cannot be estimated from available data):

Ÿ Decreased platelets (blood clotting cells)

Ÿ Hallucinations

Ÿ Problems with abnormal movements such as writhing, jerking movements and stiﬀness

Ÿ Ringing in the ears

Ÿ A group of side eﬀects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inﬂammation of liver occurring together

Ÿ Yellowing of the skin and eyes (jaundice), inﬂammation of the liver Ÿ Acute kidney failure, incontinence (leakage of urine which you cannot control)

Ÿ Increased breast tissue, breast enlargement

Ÿ Adverse events following the abrupt discontinuation of gabapentin

(anxiety, diﬃculty sleeping, feeling sick, pain, sweating), chest pain Ÿ Breakdown of muscle ﬁbers (rhabdomyolysis)

Ÿ Change in blood test results (creatine phosphokinase increased) Ÿ Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation

Ÿ Low blood sodium level (hyponatraemia)

Ÿ Anaphylaxis (serious, potentially life threatening allergic reaction including diﬃculty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)

Ÿ Dependence and addiction (see section “How do I know if I am tolerant or addicted?”)

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

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

Drug Withdrawal

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”).

How do I know if I am tolerant or addicted?

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

Ÿ You may feel the need to keep taking the medication for longer than your doctor recommended

Ÿ You feel you need to use more than the recommended dose Ÿ You are using the medicine for reasons other than prescribed Ÿ 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 or pharmacist. 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

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. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in original package.

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 contains

The active substance is gabapentin. Each hard gelatin capsule contains 400 mg of gabapentin.

The other ingredients are:

Capsule contents: lactose monohydrate, maize starch and puriﬁed talc. Capsule shell: gelatin, puriﬁed water and sodium lauril sulfate, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172)

What gabapentin looks like and contents of the pack

The 400 mg capsules are orange cap with orange body hard gelatin size “0” capsule ﬁlled with white granular powder.

Capsules are packed in PVC/PVDC/aluminium foil blister packs of 30 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

DAWA Limited

5 Sandridge Close

Harrow, Middlesex,

HA1 1XD, UK

Manufacturer

Drugsrus Limited