Trobalt 50 mg film-coated tablets

Trobalt is one of a group of medicines called antiepileptics. It works by preventing the brain overactivity that causes epileptic seizures (also called fits).

It is used with other medicines to treat adults who have a form of epilepsy, that affects one part of the brain, called partial onset seizures. These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Do not take Trobalt
- if you are allergic ( hypersensitive) to retigabine or any of the other ingredients of Trobalt (listed in section 6).
Tell your doctor if this applies to you, and don?t take Trobalt.

Take special care with Trobalt

Before you take Trobalt your doctor needs to know:
- if you are 65 years of age or above.
- if you have kidney or liver problems.
Tell your doctorif any of these applies to you. The doctor may decide to give you a reduced dose.

Trobalt is not recommended for children aged under 18. The safety and effectiveness are not yet known in this age group.

Look out for serious symptoms

Trobalt can cause serious side effects, including an inability to pass urine ( urinary retention) and mental health problems. You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems. See 'Look out for serious symptoms' in section 4.

Heart conditions

Trobalt can affect heart rhythm. This is more likely to affect you:
- if you are taking other medicines
- if you have an existing heart problem
- if you have low potassium ( hypokalaemia) or low magnesium ( hypomagnesaemia) in your blood.
- if you are 65 years of age or above
Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow). You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while you are taking Trobalt.

Thoughts of harming yourself or suicide
A small number of people being treated with antiepileptics such as Trobalt have had thoughts of harming or killing themselves. If at any time you have these thoughts,
Immediately contact your doctor.

If you need a blood or urine test

Trobalt can affect the results of some tests. If you need a blood or urine test:
Tell the person who orders the test that you are taking Trobalt.

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

Trobalt may increase the level of digoxin (used to treat heart problems) in your blood. Tell your doctor if you are taking digoxin.

Trobalt may affect some anaesthetics (for example thiopental sodium). If you are going to have an operation under a general anaesthetic:
Tell the doctor that you are taking Trobalt, well in advance.

Alcohol and Trobalt

Drinking alcohol with Trobalt can make your vision blurred. Take extra care until you know how Trobalt and alcohol affect you.

Pregnancy and breast-feeding

You must only take Trobalt during pregnancy if your doctor tells you. There is no information about the safety of Trobalt in pregnant women. You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
Talk to your doctor if you are pregnant, think you could be pregnant, or if you plan to become pregnant. Do not stop treatment without first discussing it with your doctor.

It is not known whether the ingredients of Trobalt can pass into breast-milk.
Talk to your doctor about breast-feeding while you are taking Trobalt. The doctorwill weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.

Driving and using machines
Trobalt can make you feel dizzy or drowsy and cause double or blurred vision.
Don?t drive or use machines until you know how Trobalt affects you.

You must talk to your doctor about the effect of your epilepsy on driving and using machines.

Always take Trobalt exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

How much to take

The usual maximum starting doseof Trobalt is 100 mg, taken three times a day (a total of 300 mg a day). Your doctor may gradually adjust your dose over a few weeks so that your seizures are better controlled, and side effects are kept to a minimum. The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day). If you are over 65 years you will usually be given a reduced starting dose and your doctor may limit the maximum dose to 900 mg a day.

If you have kidney or liver problems,your doctor may give you a reduced dose of Trobalt.

Don?t take any more Trobalt than your doctor has recommended. It may take a few weeks to find the right dose of Trobalt for you.

How to use a Treatment Initiation Pack

You may have been given a ?Treatment Initiation Pack? to start your treatment with Trobalt. This pack contains all the Trobalt tablets you will need to take during your first two weeks of treatment. The tablets are contained in two blister wallets, marked week 1 and week 2. During your first week of treatment (days 1 to 7), you should take one 100 mg tablet three times a day. During the second week of treatment (days 8 to 14), you should take one 100 mg tablet and one 50 mg tablet together, three times a day.

How to take

Swallow the tablet whole. Don?t chew, crush or split the tablet. You can take Trobalt with or without food.

If you take more Trobalt than you should
If you taketoo many tablets of Trobalt, you may be more likely to have side effects, or any of these symptoms:
- feelingagitated, aggressive or irritable
- effects on heart rhythm.
Contact your doctor or pharmacist for adviceif you ever take more Trobalt than you are prescribed. If possible, show them the medicine pack.

If you forget to take Trobalt
If you miss any doses, just take one dose as soon as you remember. Then leave at least 3 hours before your next dose.
Don't take more than one dose at a time to make up for missed doses. If you are not sure what to do, ask your doctor or pharmacist.

Don?t stop taking Trobalt without advice

Take Trobalt for as long as your doctor recommends. Don?t stop unless your doctor advises you to.

If you suddenly stop taking Trobalt, your seizures may come back or get worse. Do not reduce your dose unless your doctor tells you to. To stop taking Trobalt, it is important that the dose is reduced gradually, over at least 3 weeks.

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

Look out for serious symptoms

Problems passing urine
These are common in people taking Trobalt, and can lead to not being able to pass urine at all. This is most likely to happen during the first few months of treatment with Trobalt. Symptoms include: - pain when passing urine ( dysuria)
- difficulty in starting to urinate ( urinary hesitation)
- not being able to pass urine ( urinary retention).
Tell your doctor immediately if you get any of these symptoms.

Mental health problems
These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment. Symptoms include:
- confusion
- psychotic disorders (severe mental health problems)
- hallucinations(seeing or hearing things that are not there).
Tell your doctor as soon as possible if you get any of these symptoms. Your doctor may decide that Trobalt is not suitable for you.

Very common side effects

These may affect more than 1 in 10 people:
- dizziness
- drowsiness
- lack of energy.
If any of these effects gets serious, tell your doctor or pharmacist.

Common side effects

These may affect up to 1 in 10 people:
- blood in the urine; abnormally coloured urine
- feeling disorientated; anxiety
- memory problems ( amnesia)
- difficulty in reading, writing or saying what you mean, or difficulty in understanding words - attention problems
- lack of co-ordination; spinning sensation ( vertigo); balance problems; problems walking - tremors; sudden jerking of muscles ( myoclonus)
- tingling or numbness of the hands or feet
- double or blurred vision
- constipation; feeling sick ( nausea); indigestion; dry mouth
- weight gain; increased appetite
- swelling of lower legs and feet
- feeling weak or generally unwell
- changes in liver function, which will show up in blood tests.
If any of these effects gets serious, tell your doctor or pharmacist.

Uncommon side effects

These may affect up to 1 in 100 people:
- slow or reduced muscle movement
- difficulty in swallowing
- skin rash
- excessive sweating
- kidney stones.

Elderly

If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
- drowsiness
- memory problems
- balance problems, lack of co-ordination, spinning sensation ( vertigo), problems walking - tremors

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.

Keep out of the reach and sight of children.

Do not use Trobalt after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not store above 25-C.

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.

What Trobalt contains

The active substance is retigabine. Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, macrogol 3350, titanium dioxide (E171) and talc (E553b). The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
The 200 mg tablets also contain iron oxide yellow (E172).

What Trobalt looks like and contents of the pack

Trobalt 50 mg tablets are purple, round and marked ?RTG 50? on one side. Each pack contains blisters of 21, 84 or 168 film-coated tablets.

Trobalt 100 mg tablets are green, round and marked ?RTG 100? on one side. Each pack contains blisters of 21, 84 or 168 film-coated tablets.

Trobalt 200 mg tablets are yellow, oblong and marked ?RTG-200? on one side. Each pack contains blisters of 84 or 2 x 84 film-coated tablets.

Trobalt 300 mg tablets are green, oblong and marked ?RTG-300? on one side. Each pack contains blisters of 84 or 2 x 84 film-coated tablets.

Trobalt 400 mg tablets are purple, oblong and marked ?RTG-400? on one side. Each pack contains blisters of 84 or 2 x 84 film-coated tablets.

A Treatment Initiation Pack is also available for use during the first two weeks of treatment when the dose is being slowly increased. The Treatment Initiation Pack contains 63 tablets, in 2 blisters. The blister for Week 1 of treatment contains 21 x 100 mg tablets. The blister for Week 2 contains 21 x 50 mg tablets and 21 x 100 mg tablets.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.

Manufacturer

Treatment Initiation Pack ? Catalent UK Packaging Limited, Sedge Close, Headway, Great Oakley, Corby, Northamptonshire NN18 8HS, United Kingdom.

All other packs ? Glaxo Wellcome, S.A, Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

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Polska

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

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Lietuva

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info.lt@gsk.com

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