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Gabapentin Bristol Labs 300mg Capsules

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24 mm

24 mm

1. What Gabapentin Capsules are and what they are used for


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Package leaflet: Information for the user Gabapentin Bristol Labs 100 mg Capsules Gabapentin Bristol Labs 300 mg Capsules Gabapentin Bristol Labs 400 mg Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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. 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._

What is in this leaflet:

1.    What Gabapentin Capsules are and what they are used for

2.    What you need to know before you take Gabapentin Capsules

3.    How to take Gabapentin Capsules

4.    Possible side effects

5.    How to store Gabapentin Capsules

6.    Contents of the pack and other information

The name of your medicine is Gabapentin Capsules and it contains the active ingredient gabapentin 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).

•    Your doctor will prescribe Gabapentin for you to help treat your epilepsy when your current treatmentis not fully controlling your condition. You should take Gabapentin in addition to your 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 Capsules

Do not take Gabapentin Capsules:

•    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 capsules:

•    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 sickand being sickcontactyour doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas)

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 antiepileptics 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

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 nottreated. You need to know these symptoms to look out for while you are taking Gabapentin.

Read the description of these symptoms in section 4 of this leaflet under 'Contactyour 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 atthesame 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 Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing opiods such as morphine If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opiods may cause symptoms like sleepiness and/or decrease in breathing.

Antacids for indigestion

If Gabapentin and antacids containing aluminium and magnesium are taken atthe same time, 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 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 Capsules with food and drink and alcohol

The capsules can be taken with or without food. Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentin should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of childbearing potential.

There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, thinkyou 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 Capsules 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 capsules contain Lactose

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 Capsules

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you.

Method and route of administration

For oral use only. Always swallow the capsules or tablets whole with plenty of water.

Continue taking Gabapentin until your doctor tells you to stop.

Epilepsy, the usual dose is:

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 treatmentis 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 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.

Peripheral Neuropathic Pain, the usual dose is: Adults:

Take the number of capsules or 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.

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4. Possible Side Effects


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 elderiy 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.

If you take more Gabapentin Capsules 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.

If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin capsules may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance.

If you forget to take Gabapentin Capsules 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 Capsules Do not stop taking Gabapentin Capsules unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin Capsules suddenly or before your doctor tells you, there is an increased risk of seizures.

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

Like all medicines, Gabapentin Capsules can cause side effects, although not everybody gets them. 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)

•    Gabapentin Capsules 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 musde pain

•    frequent infections

If you are on haemodialysis, tell your doctor if you

develop musde 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 to1 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

SAME SIZE ARTWORK

240 x 170 mm

Back

5. How to store Gabapentin Capsules


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

Uncommon: may affect up to 1 in 100 people:

•    Mental impairment

•    Decreased movement

•    Racing heartbeat

•    Swelling that may involve the face, trunk and limbs

•    Abnormal blood test results suggesting problems with the liver

•Fall

•    Difficulty with thinking

•    High blood sugar (most often observed in patients with diabetes)

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

•    Loss of consciousness

•    Low blood sugar (most often observed in patients with diabetes)

Not known: frequency cannot be estimated from the available data

•    Decreased platelets (blood clotting cells)

•    Hallucinations

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

•    Ringing in the ears

•    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

•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,

•    Blood glucose fluctuations in patients with diabetes.

•    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

•    Hyponatraemia 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. By reporting side effects you can help provide more information on the safely of this medicine.

•    Keep out of sight and reach of children.

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

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

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist 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 100mg, 300mg or 400mg Gabapentin. The other ingredients are:

•    Capsule fill: Lactose Monohydrate, Maize Starch, Talc.

•Capsule shell: Gelatin, Titanium dioxide (El71) The 300mg Capsules contain Yellow Iron Oxide (El 72); the 400mg Capsules contain: Yellow Iron Oxide (E172), Red Iron Oxide (E172)

•    Printing ink: Shellac Glaze, Vegetable Carbon (E153), Antifoam, Industrial Methylated Spirit.

What Gabapentin Capsules look like and contents of the pack

100mg: Hard gelatin capsule with white cap/white body and printed with "BL 100".

300mg: Hard gelatin capsule with yellow cap/yellow body and printed with "BL 300".

400mg: Hard gelatin capsule with orange cap/ orange body and printed with "BL 400".

All strengths are available in blister pack of 10x10 capsules

Marketing    Authorisation Holder and

Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP41 EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@hristoLlahs.co.uk

Gabapentii Bristol Labs100 mg Capsiles;PL17907/0371 Gabapentii Bristol Labs300mg Capsiles;PL17907/0372 Gabapenlii Bristol Labs400mg Capsiles;PL17907/0373 This leaflet was last revised in February 2016 To request a copy of this leaflet in Braille, large print or audio formatthen please contact the licence holder at the address (or telephone, fax, email) above. §

V8 17-02-16 DO    S

170 mm


240 mm