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*    Gabapentin Mylan

400 mg Hard Capsules

100 Hard Capsules

2

Each 400 mg hard capsule contains: 400 mg

of gabapentin. This product contains: lactose monohydrate. Read the package leaflet before use. For oral use. Take as directed by the doctor. Keep out of the reach and sight of children. Do not

store above 25°C. Keep the container tightly closed. PL 04569/0667 [PO~"

482533

Mylan, Potters Bar,

Herts, EN6 ITL

lllllll

TBC

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Mylan

dioxide) and E172 (Iron oxide yellow): and the 400 mg capsules contain the colourings: E171 (titanium dioxide), E172 (Iron oxide yellow) and E172 (Iron oxide red).

What Gabapentin looks like and contents of the pack

the 100 mg capsules are white, the 300 mg capsules are yellow and the 400 mg capsules are orange.

gabapentin capsules are available in blister packs of 10, 20, 30, 50, 60, 90, 100, 200, 250, 500 or 1000 capsules or in containers of 50, 200, 100 or 250 capsules*.

* not all pack sizes may be marketed.

5. how to store gabapentin

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date, which is shown on the label, carton or bottle after 'EXP'. The expiry date refers to the last day of that month.

Store the capsules below 25 °C.

HDPE bottle: Keep the bottle tightly closed. PVC/Alu blister: Store in the 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.

•    Increase in weight.

•    Accidental injury, fracture, abrasion.

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

•    Decreased platelets (blood clotting cells) which may lead to unusual bruising or bleeding of the skin.

•    Sensing things that are not real (hallucinations).

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

•    Ringing in the ears.

•    Racing heartbeat.

•    Hair loss.

•    Adverse events following the abrupt

•    Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking.

•    Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, numbness, tingling or pins and needles, 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,

•    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

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

•    Allergic reactions such as skin rashes or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing.

•    Severe skin reactions which can cause blisters, sores and ulceration.

•    Liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes.

•    An inflamed pancreas which may cause abdominal pain and being sick.

•    Kidney problems leading to passing less urine than usual, and feeling sick, tired or confused.

If you take more Gabapentin than you should

Call your doctor or go to 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.

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 stop taking Gabapentin unless your

doctor tells you to. If your treatment is stopped

LEAVE BLANK

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02

Gabapentin Mylan 400 mg Hard Capsules

I00 Hard Capsules

2

Each 400 mg hard capsule contains: 400 mg

of gabapentin. This product contains: lactose monohydrate. Read the package leaflet before use. For oral use. Take as directed by the doctor. Keep out of the reach and sight of children. Do not

store above 25°C. Keep the container tightly closed.

PL 04569/0667 [POM    _

482533

Mylan, Potters Bar,

Herts, EN6 ITL

llllllll

TBC

m

Mylan

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 ITL, United Kingdom.

Manufacturers

Gerard Laboratories, 35/36 Baldoyle Industrial estate, grange Road, Dublin 13, Ireland. generics [Uk] Limited, Station close, Potters Bar, Hertfordshire, EN6 1TL United kingdom.

Date of revision August 2014

31

package leaflet: information for the patient GABAPENTIN MYLAN 100 mg HARD CAPSULES GABAPENTIN Mylan 300 mg

hard capsules

GABAPENTIN MYLAN 400 mg HARD cAPsuLEs

(gabapentin)

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.

5.    How to store Gabapentin

6.    Contents of the pack and other information

1. what gabapentin is and what it is used for

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

Epilepsy

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

needles etc.

2. WHAT You NEED To KNoW BEFoRE You

take gabapentin

Do not take Gabapentin

•    if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentin.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking Gabapentin:

•    if you suffer from kidney problems

•    if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately.

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' other medicines and Gabapentin Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

Gabapentin with food and drink

Gabapentin can be taken with or without food (see section 3 'How to take Gabapentin'). pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.

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 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

Gabapentin, is excreted in human milk.

Because the effect on the nursing infant is unknown, it is not recommended to breastfeed your baby while taking Gabapentin. Driving and using machines Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.

Gabapentin contains lactose

The capsules contain lactose. If you have

been told by your doctor that you have an

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.

Always swallow the capsules whole with plenty of water.

Continue taking Gabapentin until your doctor tells you to stop.

Epilepsy:

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 stepwise

•    This medicine has been prescribed for you only. 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.

What is in this leaflet:

1.    What Gabapentin is and what it is used for

2.    What you need to know before you take Gabapentin

3.    How to take Gabapentin

4.    Possible side effects

6. contents of the pack and other information

What Gabapentin contains

The active substance is gabapentin.

Each hard capsule contains either 100 mg, 300 mg or 400 mg gabapentin.

The other ingredients in Gabapentin capsules are:

Capsule contents: Lactose anhydrous, maize starch and talc.

Capsule shell: gelatin.

The 100 mg capsules contain the colouring E171 (Titanium dioxide); the 300 mg capsules contain the colourings: E171 (Titanium

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treatment is 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 Gabapentin is used to treat long lasting pain caused by damage to the nerves. A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and

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

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 these symptoms to look out for while you are taking Gabapentin.

Gabapentin is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.

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

If Gabapentin and antacids 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 is taken at the earliest two hours after taking an antacid.

the foetus, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.

Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.

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

intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take gabapentin

Always take Gabapentin 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.

If you have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Gabapentin normally except if you have problems with your kidneys.

up to a maximum 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.

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/kg/day. It is usually given in 3 divided doses, by taking the capsule(s) each day, usually once in the morning, once in

Date: 15 SEP 2014

Time: 08:55

discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain.

• Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver. Additional side effects in children and adolescents:

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

•    Incontinence.

•    Difficulties with erection.

•    Failure to reach orgasm (female).

•    Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms.

taking Gabapentin. 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 side-effects which may affect more than 1 person in 100 are listed below:

•    Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear

•    Loss of appetite or an increased appetite.

These side effects are serious. You may need medical attention.

Tell your doctor if you suffer from a sore throat, fever, severe chills and mouth ulcers. This can be due to a lack of white blood cells. 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:

it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin 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 product, ask your doctor or pharmacist.

4. possible side effects

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

If any of the following happen, stop taking Gabapentin and tell your doctor immediately or go to your nearest hospital emergency department:

the afternoon and once in the evening. Gabapentin is not recommended for use in children below 6 years of age. peripheral Neuropathic pain:

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 stepwise up to a maximum 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.

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Page Count

1/1

Myriad Pro

60 x 47mm

PMS

Rhodamine Red 2905

Body Text Size

8 pt