Trobalt
retigabine
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 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 Trobalt is and what it is used for
What you need to know before you take Trobalt
How to take Trobalt
Possible side effects
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How to store Trobalt
Contents of the pack and other information
Trobalt contains the active substance retigabine. Trobalt is one of a group of medicines called antiepileptics. It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation). It is used together with other anti-epileptic medicines to treat adults who continue to experience seizures and where other combinations of antiepileptic medicines have not worked well.
if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6).
Talk to your doctor before taking Trobalt:
if you are 65 years of age or above.
if you have kidney or liver problems.
Tell your doctor if any of these applies to you. The doctor may decide to give you a reduced dose.
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.
Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Discolouration of parts of the eye, including the retina (inside the back of the eye) has been reported in people taking Trobalt for several years (see Section 4).
Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in
people taking Trobalt (see Section 4).
Your doctor should recommend that you have an eye examination before starting treatment. The eye examination should be repeated at least every six months whilst taking Trobalt. Treatment will be stopped if any problems are found unless no other suitable treatments are available. Your doctor will monitor you more closely if treatment with Trobalt is continued.
Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
A blue-grey discolouration of the skin, lips or nails has also been reported in people taking Trobalt for several years (See Section 4). This sometimes occurs together with discolouration of parts of the eye. If you notice such changes while taking the medicine, tell your doctor.
Your doctor will discuss with you whether treatment with Trobalt should be continued.
Heart conditions
Trobalt can affect heart rhythm. This is more likely to affect you:
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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.
Trobalt is not recommended for children and adolescents aged under 18. The safety and efficacy are not yet known in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
Drinking alcohol with Trobalt can make your vision blurred. Take extra care until you know how Trobalt and alcohol affect you.
There is no information about the safety of Trobalt in pregnant women. Therefore Trobalt is not recommended during pregnancy.You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not stop treatment without discussing it with your doctor. The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
It is not known whether the active substance of Trobalt can pass into breast-milk.
Talk to your doctor about breast-feeding while you are taking Trobalt. Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
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.
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Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
The maximum starting dose of 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.
Trobalt is for oral use. Swallow the tablet whole. Don’t chew, crush or split the tablet. You can take Trobalt with or without food.
If you take too many tablets of Trobalt, you may be more likely to have side effects, or any of these symptoms:
feeling agitated, aggressive or irritable
effects on heart rhythm.
Contact your doctor or pharmacist for advice if you ever take more Trobalt than you are prescribed. If possible, show them the medicine pack.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Trobalt can cause side effects, although not everybody gets them.
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In some cases changes to the pigmentation in the eyes may improve after you stop taking Trobalt. Your doctor should recommend that you have an eye examination before starting treatment. The eye
examination should be repeated at least every six months whilst taking Trobalt. Treatment will be
stopped if any problems are found unless no other suitable treatments are available. Your doctor will monitor you more closely if treatment with Trobalt is continued.
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.
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.
These may affect more than 1 in 10 people:
dizziness
drowsiness
lack of energy.
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)
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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.
These may affect up to 1 in 100 people:
slow or reduced muscle movement
difficulty in swallowing
skin rash
excessive sweating
kidney stones.
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 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
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, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan
gum.
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).
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The 200 mg tablets also contain iron oxide yellow (E172).
Trobalt 50 mg film-coated tablets are purple, round and marked “RTG 50” on one side. Each pack contains blisters of 21or 84 film-coated tablets.
Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side. Each pack contains blisters of 21or 84 film-coated tablets.
Trobalt 200 mg film-coated 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 film-coated 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 film-coated tablets are purple, oblong and marked “RTG-400” on one side. Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Not all pack sizes may be available in your country.
Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
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:
Tél/Tel: + 32 (0)10 85 52 00
GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
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GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GlaxoSmithKline A.E.B.E.
Τηλ: + 30 210 68 82 100
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
GlaxoSmithKline (GSK) S.R.L. Tel: + 4021 3028 208
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
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GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00
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Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina. Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Medicinal product no longer authorised
Therefore, based upon the safety profile of Trobalt the CHMP concluded that the MAH should submit one additional renewal application in 5 years.