TROBALT 200 mg. 84 tablets

What is Trobalt and what is it used?
Trobalt belongs to a group of medicines called antiepileptics. The drug acts by preventing excessive brain activity that leads to seizures (also called fits).
Used together with other antiepileptic medicines to treat adults with "difficult to control" proceed with partial onset that can not tolerate other anti-epileptic drugs or where other antiepileptic drugs did not have a good effect.

2. What you need to know before you take Trobalt?
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 do not take Trobalt.

Warnings and Precautions
Talk to your doctor before taking Trobalt:
• if you are aged 65 and over.
• if you have problems with your kidneys or liver.
Tell your doctor if any of the statements above apply to you. The doctor may decide to give you a reduced dose.
Watch for signs of serious symptoms
Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems. You should watch for certain symptoms while you are taking Trobalt, to reduce the risk of problems. See "Watch out for serious symptoms' in section 4.

Discoloration of skin, nails, lips and eyes
Change in color of the parts of the eye, including the retina (the back of the eye) has been reported in patients taking Trobalt for several years (see section 4). Your doctor should recommend an eye examination before starting treatment. The eye examination should be repeated at least every six months, while you are taking Trobalt. If any problems, this treatment will be stopped, unless no other therapeutic options are inappropriate. If treatment with Trobalt continue, your doctor will monitor you more closely.
Tell your doctor if you notice any changes in your vision while being treated with Trobalt.
Bluish-gray discoloration of the skin, lips or nails have also been reported in patients taking Trobalt for several years (see section 4). This sometimes occurs with a change in color of the parts of the eye. If you notice any changes while taking this medicine, tell your doctor.
Your doctor will discuss with you whether Trobalt must continue. Heart condition

Trobalt may affect heart rhythm. More likely this happen to you:
• if you are taking other medicines
• if you have existing heart problem
• if you have low potassium levels (hypokalemia) or low levels of magnesium (hypomagnesemia) in the blood.
• if you are aged 65 and over.
Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (too fast or too slow heart rate). You may need to give you further investigations (including an electrocardiogram [ECG], which shall record the electrical activity of your heart) while you are taking Trobalt.

Thoughts of harming 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 should have a blood test or urine
Trobalt may affect the results of some research. If you should have a blood test or urine:
Inform specialist who places the studies that take Trobalt.
Children and adolescents
Trobalt is not recommended for children under the age of 18 years. Safety and efficacy in this age group are not yet known.

Other medicines and Trobalt
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Trobalt may affect some anesthetics (for example thiopental sodium). If you have an operation under general anesthesia:
Tell your doctor early enough that you are taking Trobalt.

Trobalt and alcohol
Drinking alcohol with Trobalt may obscure your vision. Be cautious until you know how Trobalt affects the combination and alcohol.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
You should take Trobalt during pregnancy if your doctor tells you to. Information on the safety of Trobalt in pregnant women. You must use a reliable method of contraception to avoid becoming pregnant while being treated with Trobalt.
Ask your doctor if you are pregnant, think you may be pregnant or planning 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.
Ask your doctor about breast-feeding while you are taking Trobalt. He will weigh the benefit to you against the risk to your baby of taking Trobalt, while breastfeeding.

Driving and using machines
Trobalt may make you feel dizzy or drowsy or cause double or blurred vision.
Do not drive or operate machinery until you know how you affect Trobalt.
You should discuss with your doctor the effect of epilepsy on your ability to drive and use machines.

3. How to take Trobalt?
Always take Trobalt exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

How much to take?
The usual maximum starting dose of Trobalt is 100 mg, taken three times daily (total dose 300 mg daily). Your doctor may gradually adjust your dose over several weeks in order to proceed you better control and side effects can be minimized. The maximum dose is 400 mg, taken three times a day (total of 1200 mg daily). If you are over 65, you will start with a reduced initial dose, your doctor may reduce the maximum dose to 900 mg daily.
If you have kidney or liver problems, your doctor may give you a lower dose of Trobalt.
Do not take more Trobalt, than prescribed by your doctor. It may take several weeks to find the dose of Trobalt, which is suitable for you.

How to use the package to start treatment?
You have been given "Package to initiate treatment" to start your treatment with Trobalt. This pack contains all tablets Trobalt, you will need to take the first two weeks of treatment. Tablets are two packages for blisters type "portfolio" with indications week 1 and week 2. During the first week of treatment (days 1 to 7), you should take one 100 mg tablet three times a day. In the second week of treatment ( days 8 to 14) should not take the same time as one tablet of 100 mg and a 50 mg tablet three times daily.

How to take the tablets?
Swallow the tablets whole. Do not chew, crush or split. You can take Trobalt with or without food.

If you take more Trobalt dose
If you take too many tablets of Trobalt, may increase the likelihood of side effects, or any of these symptoms:
• feel agitated, aggressive or irritable
• effects on heart rhythm.
Contact your doctor or pharmacist for advice if you ever take more Trobalt than your prescribed dose. If possible, show them the medicine pack.

If you forget to take Trobalt
If you miss a dose, take a dose as soon as you remember. Then take the next dose at least 3 hours.
Do not 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.

Do not stop taking Trobalt, without the counsel
Take Trobalt for as long as recommended by your doctor. Do not stop unless your doctor tells you to do so.

If you stop taking Trobalt
If you stop taking Trobalt sudden attacks may recur or worsen. Do not reduce your dose unless your doctor tells you to. To stop taking Trobalt, it is important to reduce the dose gradually over a period of at least 3 weeks.

4. Possible side effects
Like all medicines, Trobalt can cause side effects, although not everybody gets them.
Watch for signs of serious symptoms
Change in color of the parts of the eye, including the retina (the back of the eye), this may be very common in people taking Trobalt for several years. Your doctor should recommend an eye examination before starting treatment. The eye examination should be repeated at least every six months, while you are taking Trobalt. If any problems, this treatment will be stopped, unless no other therapeutic options are inappropriate. Your doctor will monitor you more carefully if treatment with Trobalt continue.
Bluish-gray discoloration of the skin, lips or nails: it is very common in people taking Trobalt for several years. This sometimes occurs simultaneously with the change in color of the parts of the eye. Your doctor will discuss with you whether Trobalt must continue.

Problems with passing urine
These problems are common in people taking Trobalt, and can lead to a complete inability to pass urine. The probability of this happening is greatest in the first few months of treatment with Trobalt. Symptoms include:
• pain when passing urine (dysuria)
• difficulty in starting urination (dysuria)
• inability to pass urine (urinary retention).
Tell your doctor if you experience any of these symptoms.

Mental health problems
These problems are common in people taking Trobalt, and the probability of this happening is greatest in 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
They can 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; unusual color of urine
• feeling disorientated; anxiety
• memory problems (amnesia)
• difficulty in reading, writing or saying what you want, or difficulty in understanding words
• attention problems
• lack of coordination; dizziness (vertigo); balance problems; problems when walking
• tremor; sudden muscle spasm (myoclonus)
• tingling or numbness in hands or feet
• double or blurred vision
• constipation; nausea; digestive problems; dry mouth
• weight gain; increased appetite
• swelling of the lower legs and feet
• feeling of weakness or feeling unwell
• changes in liver function, which will show up in blood tests.
If any of these side effects gets serious, please tell your doctor or pharmacist.

Uncommon side effects
These may affect up to 1 in 100 people:
• delayed or restricted movement of muscles
• difficulty swallowing
• skin rash
• excessive sweating
• kidney stones.

Elderly
If you are aged 65 and over in your chance of getting the below symptoms is greater compared to younger adults:
• drowsiness
• memory problems
• impaired balance, lack of coordination, dizziness (vertigo), problems walking
• tremor.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system referred to in Annex V. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Trobalt?
Keep out of the reach and sight of children.
Do not use Trobalt after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medications in 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 Trobalt?
The active substance is retigabine. Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171), talc (E553b), lecithin (SOY) and xanthan gum.
Tablets 50 mg and 400 mg also contain indigo carmine aluminum lake (E132) and carmine (E120).
Tablets of 100 mg and 300 mg also contain indigo carmine aluminum lake (E132) and iron oxide yellow (E172).
The 200 mg tablets also contain yellow iron oxide (E172). Trobalt looks like and contents of the pack
Trobalt 50 mg tablets are blue-purple, round and marked "RTG 50" on one side. Each pack contains blisters of 21, 84 or 168 tablets.