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1. Gabapentin Genus Pharmaceuticals 100mg Hard Capsules
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Package leaflet: Information for the user Gabapentin Genus Pharmaceuticals 100 mg, 300mg and 400mg hard capsules

Gabapentin

What is in this leaflet:

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

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

3.    How to take Gabapentin Genus Pharmaceuticals Capsules

4.    Possible side effects

5.    How to store Gabapentin Genus Pharmaceuticals Capsules

6.    Contents of the pack and other information

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

Gabapentin belongs t o a group of medicines used t o treat epilepsy and peripheral neuropathic pain.

The active ingredient in Gabapentin Genus Pharmaceuticals Capsules is gabapentin.

Epilepsy: Gabapentin is used to tr eat various forms of epilepsy (a brain disorder involvin g repeated se izures). You r doctor will prescri be you Gabapentin to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin in addition to your current treatment unless told otherwise.

The application of Gaba pentin together with oth er epilepsy medicines is used to tre at adults and children aged 6 years and above.

Gabapentin can also be used on its own to treat adults and children over 12 years of age.

Peripheral neuropathic pain (Neuropathy): Gabapentin is used to tr eat long lasting pain caused by damage to the nerves in adults. A variety o f different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, such as diabetes or shingles. Pain sensations may be d escribed as hot, burnin g, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.

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

DO NOT take Gabapentin Genus Pharmaceuticals Capsules

•    if you are allergic 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 Genus Pharmaceuticals.

•    if you develop thoughts of killing or harming yourself. 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.

•    if you suffer from kidney problems please inform your doctor before taking Gabapentin

•    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 stom ach pain, feeling sick a nd being sick contact your doctor immediately as these may be s ymptoms of acute pancreatitis (an inflame d pancreas).

Important information about potentially serious reactions

A small nu mber of people taking Gabapentin Genus Pharmaceuticals Capsule s get an allergic reaction or pote ntially serio us skin rea ction, which may devel op into more serio us problems if they are not treated. You need to know these symptoms to l ook out for while you are taking Gabapentin.

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 discolouration 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 Genus Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any medicines containing morphine, please tell your d octor or pharmacist as morphine may increase the effect of Gabapentin.

Gabapentin is not expected to affe ct other anti-epileptic drugs or the oral contraceptive pill.

Gabapentin ma y interfe re with some laboratory tests, if yo u require a urine test tell your doctor or hospital that you are taking Gabapentin.

If Gabapentin Genus Pharmaceuticals Capsules and antacids (e.g. to treat heartburn or acid indigestion) containing aluminium and magnesium are taken at the same time, absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that Gabapentin Genus Pharmaceuticals Capsules are taken at the earliest 2 hours after taking an antacid.

Gabapentin with food

Gabapentin can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feedin g, think you may be pre gnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentin should not be taken d uring pregn ancy, unless you are told otherwise by you r doctor. Effective contraception must be used by women of child-bearing potential.

There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications u sed to treat seizures ha ve reported an increased risk of harm to th e unborn child, particularly when more than one seizure medication is taken at the same time.

Therefore, whenever possible and only under the advice of your doct or, you sho uld try to take only one seizure medication during pregnancy.

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.

Contact your doctor immediately if you becom e pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Genus Pharmaceuticals Capsules

Breast-feeding

Gabapentin, the active substance of Gabap entin Genus Pharmac euticals Ca psules, is excreted in human mil k. Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using Gabapentin Genus Pharmaceuticals Capsules

Driving and using machines

Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or engage in other pote ntially haza rdous activities until you know whether this medication affects your ability to perform these activities.

Gabapentin Genus Pharmaceuticals Capsules contains lactose

This medicinal product contains lactose. If y ou 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 Genus Pharmaceuticals Capsules

Always take Gabapentin Genus Pharmaceutical s Capsu les 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 have the impression that the effect of Gabapentin Genus Pharma ceuticals Capsules are too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), yo u can take Gabapentin Genus Pharmaceuticals Capsules normally except if you have problems with your kidneys (dose adjustment required).

Continue taking Gabapentin until your doctor tells you to stop.

Method and route of administration

Gabapentin is for oral u se. Always swallow the capsules whole with plenty of water (e.g. a glass of water).

Peripheral Neuropathic Pain (Neuropathy), the usual dose is:

Adults:

Take the nu mber of capsules a s instructed by your doctor. Your doctor will usually build up your dose gradually. The starting d ose will gen erally be between 300 mg and 900 mg each day. Thereafter, the do se may be in creased gradually up to a maximu m of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.

Epilepsy, the usual dose is:

Adults and adolescents:

Take the number of c apsules as instructed. Your doctor will usually build up your dose gradually. The starting dose will g enerally be between 300 mg and 900 mg each day . Thereafter, the dose may be increased gradually up to a maximum of 3600 mg each day and your doctor will tell you to take th is in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.

The maximum time period between the doses should n ot exceed 12 hours to prevent breakthrough convulsions.

Children aged 6 years and above:

The dose to be given to your child will be deci ded by your doctor as it is cal culated against your child’s weight. Th e treatment is started with a low initial dose which is g radually increased over a period of approximately 3 da ys. The usual dose to control epilep sy is 2535 mg per kilo of bodyweight per da y. It is usua lly given in 3 divided d oses, by ta king the capsule(s) each day, u sually once in the morning, once in the afternoon and once in the evening.

The maxi mum time period between the doses should n ot exceed 12 hours to prevent breakthrough convulsions.

Gabapentin is not recommended for use in children below 6 years of age.

If you have kidneys 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 take more Gabapentin Genus Pharmaceuticals Capsules than you should

Call your doctor or go t o the nearest hospital emergency unit immediately. Take along any capsules that are left, the container and the label so that the hospital can easily tell what medicine you have taken.

Higher than recommended doses may result in an increa se in undesirable effects including loss of con sciousness, dizziness, double vision, slurred speech, drowsiness, let hargy and mild diarrhoea.

If you forget to take Gabapentin Genus Pharmaceuticals 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 Genus Pharmaceuticals Capsules

Do not stop taking Gabapentin Genus Pharma ceuticals 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 ta king Gabap entin Genus Pharmaceuticals 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.

4. Possible side effects

Like all medicines, this medicine 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

•    if you de velop severe skin reactio ns like swelling of the lips and face, skin rash and redness (these may be symptoms of a serious allergic reaction)

•    if you deve lop signs such as persistent sto mach pain, feeling sick and being sick (symptoms of an inflammation of the pancreas)

•    if you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness

•    Gabapentin Genus Pharmaceuticals Capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of yo ur body such as your liver or blood cells. You may o r may not h ave rash when you get this type of reaction. It may cause you to be hospitalised or to stop Gabapentin Genus Pharmaceuticals. Capsules

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 Genus Pharmaceuticals Capsules

The following frequencies are used in evaluating side effects:

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 i nfection, inflammation of the ear or other infections

•    Low white blood cell counts

•    Anorexia, increased appetite

•    Anger towa rds others, confusion, mood cha nges, depression, anxiety, nervou sness, difficulty with thinking

•    Convulsions, jerky move ments, difficulty with speaking, loss of memory, tremor, difficulty sleeping, h eadache, sensitive skin, decreas ed sensatio n (numbne ss), difficult y with coordination, unusual eye movement, increased, decreased or absent reflexes

•    Blurred vision, double vision

•    Vertigo (a specific type of dizziness)

•    High blood pressure, flushing or dilation of blood vessels

•    Difficulty breathing, bronchitis, sore throat, cough, dry or runny 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

•    Incontinence

•    Difficulties getting an erection (impotence)

•    Swelling in the legs and arms, difficulty with wal king, weakness, pain, feeling unwell, flulike symptoms

•    Decrease in white blood cells, increase in weight

•    Accidental injury, fracture, abrasion

Additionally in clinical st udies in children, aggressive behaviour and jerky mo vements were reported as common.

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

•    Allergic reactions such as hives

•    Decreased movement

•    Racing heart beat

•    Swelling that may involve the face, trunk and limbs

•    Abnormal blood test results suggesting problems with the liver

Since introduction to the market the following side-effects have been reported:

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

•    Inflammation of the pancreas

•    Inflammation of the liver, yellowing of the skin and eyes

•    Severe skin reactions t hat require immediate medical attention, swelling of the lips an d face, skin rash and redness, hair loss

•    Acute kidney failure

•    Adverse events following the abrupt discontinuation of gabapentin (anxiety, dif ficulty sleeping, feeling sick, pain, sweating), chest pain

•    Increased breast tissue, breast enlargement

•    Sudden unexplained life-threatening conditions have been reported but it was not clear whether this was due to treatment with gabapentin

•    Blood glucose fluctua tions in pa tients with diabetes, abnormal blood test r esults suggesting problems with the liver

•    Breakdown of muscle fibres (rhabdomyolysis)

•    Change in blood test results (creatine phosphokinase increased)

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Genus Pharmaceuticals Capsules

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, bottle and blister. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Bottles: Keep the container tightly closed.

The capsules in bottles can be used for 12 weeks after first opening the bottle.

Blisters: Store in the original package. Keep blister in the outer carton.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to thro w away me dicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Genus Pharmaceuticals Capsules contains

Gabapentin Genus Pharmaceuticals 100 mg hard capsules

The active substance is gabapentin. Each capsule, hard contains 100 mg gabapentin. Gabapentin Genus Pharmaceuticals 300 mg hard capsules,

The active substance is gabapentin. Each capsule, hard contains 300 mg gabapentin. Gabapentin Genus Pharmaceuticals 400 mg hard capsules,

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

• The other ingredients in Gabapentin Genus Pharmaceuticals capsules are:

Capsule contents:

Lactose anhydrous, maize starch, talc.

Capsule shell:

Gelatine, titanium dioxide (E171).

In addition: 300 mg capsules contain iron oxide yellow (E 172).

In addition: 400 mg capsules contain iron oxide yellow (E 172), iron oxide red (E 172).

What Gabapentin Genus Pharmaceuticals Capsules look like and contents of the pack

Capsule, hard

Gabapentin Genus Pharmaceuticals 100 mg hard capsules,

Hard gelatine capsule (size 3), with white opaque body and cap.

Gabapentin Genus Pharmaceuticals 300 mg hard capsules Hard gelatine capsule (size 1), with yellow opaque body and cap.

Gabapentin Genus Pharmaceuticals 400 mg hard capsules,

Hard gelatine capsule (size 0), with orange opaque body and cap.

PVC/Alu blister or HDPE bottle with PP cap. The liner is made from polystyrene foam coated on one side with an EvaWax pressure sensitive adhesive.

Pack sizes:

PVC/Alu blister:

5, 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 120, 140, 150, 200 (2x100), 210, 250, 300, 400, 500, 1000 capsules.

As hospital pack only: 500 (5x100), 1000 (10x100) capsules.

Unit dose: 20x1,60x1, 100x1 capsule.

HDPE bottle:

50, 100, 250 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genus Pharmaceuticals, Park View House, 65 London Ro ad, Newbury, Berkshire , RG1 4 1JN, United Kingdom