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Gabapentin M&A Pharmachem 100mg Capsules

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Package Leaflet: Information for the user

GABAPENTIN

M&A Pharmachem 100mg, 300mg and 400mg 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 only. Do not pass it on to others, it may harm them, even if their symptoms 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

1.    WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY ARE USED FOR

Gabapentin belongs to a group of medicines known as anti-epileptics. Gabapentin Capsules are used to:

•    Treat epilepsy. Gabapentin can be used in addition to current treatment when epilepsy has not been fully controlled in children over 6 years and adults. It can also be used on its own to treat children over 12 years and adults.

•    Relieve peripheral neuropathic pain (long lasting pain caused by damage to nerves) caused by diseases such as diabetes or shingles.

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 Gabapentin Capsules (listed in section 6)

Warnings and precautions

Talk to your doctor before you take Gabapentin Capsules if:

-    you suffer from kidney problems

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

-    you are pregnant, trying to become pregnant or are breastfeeding

•    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 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 require an operation or visit the doctor or dentist, tell them that you are taking gabapentin. Gabapentin may interfere with some laboratory tests. If you are having a urine test, tell the clinic or hospital staff that you are taking Gabapentin.

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 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 under the heading ‘Tell your doctor or go to the nearest hospital casualty department if you have any of the following serious side effects'.

Other medicines and Gabapentin Capsules

•    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 take antacids containing aluminium and magnesium at the same time as gabapentin, absorption of gabapentin from the stomach may be reduced. Take Gabapentin Capsules at least 2 hours after taking antacids.

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

In addition, combination of Gabapentin with opioids may cause symptoms like sleepiness and/or decrease in breathing.

Gabapentin Capsules contain lactose monohydrate and sunset yellow

•    These capsules contain lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

•    Gabapentin 400mg contain sunset yellow (E110) which may cause allergic reactions.


Pregnancy, breast-feeding and fertility Pregnancy

Gabapentin Capsules should not be taken during pregnancy. 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 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 are pregnant, become pregnant or plan to become pregnant. Do not suddenly stop taking this medicine. Breast-feeding

Gabapentin is passed on through breast milk. The effect on the baby is unknown; therefore you should not breast-feed your baby unless told to by your doctor.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin may cause 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.

3.    HOW TO TAKE GABAPENTIN CAPSULES

Always take your medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide the dose that is right for you.

Gabapentin Capsules are to be swallowed with plenty of water and can be taken with or without food.

Dose for neuropathic pain:

•    Adults (over 18 years of age):

The dose is usually built up gradually, starting at 300 mg on the first day, followed by 600 mg on the second day and 900 mg on the third day. The dose may then be increased to a maximum of 3600 mg each day, given in 3 divided doses - in the morning, at midday and in the evening.

•    The dose for the elderly and those with kidney problems may be reduced.

Dose for epilepsy:

•    Adults and children over 12 years:

The starting dose is usually between 300 mg and 900 mg each day. The dose is then built up gradually each day in 3 divided doses - in the morning, at midday and in the evening. The maximum daily dose is 3600 mg.

•    Children 6-12 years of age:

The dose to be given to your child will be decided by your doctor and is calculated using your child's weight. The treatment is started using a low dose, which is gradually increased over a period of approximately 3 days. It is usually given in 3 divided doses each day, by taking the capsules in the morning, at midday and in the evening.

•    The dose for the elderly and those with kidney problems may be reduced.

Gabapentin capsules should not be given to children under 6 years of age.

If you forget to take a dose

Take it as soon as you remember unless it is nearly time for your next dose. Do not take two doses at the same time.

If you take more Gabapentin Capsules than you should If you accidentally take too many capsules, tell your doctor immediately or go to the nearest hospital casualty department. Take with you the container and any capsules that are left, so that the hospital can easily tell what medicine you have taken.

If you stop taking Gabapentin Capsules Do not stop taking Gabapentin unless your doctor tells you to. If you stop taking Gabapentin Capsules suddenly there is an increased risk of seizures, pain or discomfort. If your treatment is stopped and/or an alternative anticonvulsant medicine is added to the therapy, this should be done gradually over a minimum of one week.

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

4.    POSSIBLE SIDE EFFECTS

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

Tell your doctor immediately or go to the nearest hospital casualty department if you have any of the following serious side effects:

•    Swelling of the lips and face, skin rash (these may be symptoms of a serious allergic reaction).

•    Muscle pain and/or weakness if you are on haemodialysis.

•    Severe stomach pain (this may be a symptom of inflammation of the pancreas).

Continued overleaf


•    Thoughts of harming or killing yourself.

•    Severe skin reaction with blistering around the mouth, eyes and genitals, possibly with fever or flu-like symptoms.

•    Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as liver or blood. You may or may not have a 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 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 any of the following side effects gets worse or you are worried tell your doctor or pharmacist:

Very common side-effects

(which may affect more than 1 person in 10):

•    Viral infection, fever

•    Feeling drowsy or tired, dizziness, lack of coordination.

Common side-effects (which may affect more than 1 person in 100):

•    Pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections.

•    Low white blood cell counts.

•    Loss of (anorexia) or increased appetite.

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

•    Convulsions, jerky movements, difficulty 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.

•    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.

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

Uncommon side effects

(which may affect more than 1 person in a 1000):

•    Allergic reactions such as hives.

•    Decreased movement.

•    Racing heartbeat.

•    Swelling that may involve the face, trunk and limbs.

•    Abnormal blood test results suggesting problems with the liver.

•    Fall.

•    Mental impairment.

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

Rare (may affect up to 1 in 1000 people)

•    Loss of consciousness.

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

Since introduction to the market the following side-effects have been reported (frequency unknown):

•    Decreased platelets which may cause increased bleeding or bruising.

•    Hallucinations.

•    Abnormal movements such as writhing, jerking and stiffness, involuntary twitching.

•    Ringing in the ears.

•    Yellowing of the skin and eyes (jaundice), liver problems.

•    Acute kidney failure, incontinence.

•    Increased breast tissue, breast enlargement.

•    Side effects following sudden stopping of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain.

•    Breakdown of muscle fibres (rhabdomyolysis).

•    Change in blood test results (creatine phosphokinase increased).

•    Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.

•    Low blood sodium level.


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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE GABAPENTIN CAPSULES

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

Do not store above 25°C. Store in the original package to protect from moisture.

Do not use after the expiry date, which is stated on the blister strip and carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Gabapentin Capsules contains

•    Each capsule contains 10Omg, 300mg or 400mg of the active substance gabapentin.

•    The other ingredients are maize starch, lactose monohydrate, and talc.

•    The capsules are made from gelatin and titanium oxide. The 300mg capsule also contains yellow iron oxide (E172) and quinoline yellow (E104).The 400mg capsule also contains sunset yellow (E110).

•    The marking ink contains shellac glaze, black iron oxide, N-Butyl alcohol, industrial methyl spirit 74 OP, soya lecithin and antifoam DC150.

What Gabapentin Capsules look like and contents of the pack

The 100mg capsule is a hard white capsule marked with 'GABA 100'. The 300mg capsule is a hard yellow capsule marked with 'GABA 300'. The 400mg capsule is a hard orange capsule marked with 'GABA 400’.

They are available in packs of 90 or 100 capsules in blister strips of 10 capsules.

Marketing Authorisation Holder and Manufacturer

M&A Pharmachem Ltd, Bolton, Lancashire BL5 2AL.

This leaflet was last revised in August 2016

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