Lamotrigine Ranbaxy 50 Mg Dispersible Tablets
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Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please askyourdoctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• 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.
PACKAGE LEAFLET: INFORMATION FORTHE USER Lamotrigine Ranbaxy 25mg Dispersible Tablets Lamotrigine Ranbaxy 50mg Dispersible Tablets Lamotrigine Ranbaxy 100mg Dispersible Tablets Lamotrigine Ranbaxy 200mg Dispersible Tablets
Lamotrigine
In this leaflet:
1. What Lamotrigine are and what are they used for
2. Before you take Lamotrigine
3. How to take Lamotrigine
4. Possible side effects
5. Howto store Lamotrigine
6. Further information
1. What lamotrigine is and what it is used for
Lamotrigine belongs to a group of medicines known as anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disease.
Lamotrigine treats epilepsy by blocking signals in the brain that trigger epileptic seizures (fits)
• For adults and children aged 13 years and over, Lamotrigine can be used on its own or with other medicines, to treat epilepsy. Lamotrigine can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome.
• For children aged between 2 and 12 years, Lamotrigine can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.
Lamotrigine also treats bipolar disorder.
People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18yearsand over, Lamotrigine can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamotrigine works in the brain to have this effect.
2. Before you take lamotrigine
Do not take Lamotrigine:
• If you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamotrigine (listed in Section 6).
If this applies to you:
• Tell your doctor, and don't take Lamotrigine.
Take special care with Lamotrigine
Your doctor needs to know before you take
Lamotrigine:
■ if you have problems with your kidneys
• if you have ever developed a rash when you've taken lamotrigine or other medicines for epilepsy
■ if you are already taking medicine that contains lamotrigine.
If any of these applies to you:
• Tell your doctor, who may decide to lower your dose or that Lamotrigine, is not suitable foryou.
Watch out for i mportant symptoms
If you develop any of these symptoms after you start taking Lamotrigine, get a doctor’s help straightaway:
■ an unusual skin reaction, such as redness or rashes
■ a sore mouth or eyes
• a high temperature (fever), flu-like symptoms ordrowsiness
■ swelling around the face, or swollen glands in your neck, armpit or groin
■ unexpected bleeding or bruising, or your fingers turning blue
• a sore throat or more infections (such as colds) than usual
These symptoms are more likely to happen during the first few months of treatment with Lamotrigine, especially if you start on too high dose or if your dose is increased too quickly, or if you're taking Lamotrigine with another medicine called valporate. Children are more likely to be affected than adults.
The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated, ifyou notice any of these symptoms:
• See a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine.
Thoughts of harming yourself or suicide
Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. Ifyou have bipolar disorder, you may be more likely to think like this:
• when you first start treatment
• if you have previously had thoughts about harming yourself or about suicide
• ifyou are under25 years old
Ifyou have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you're taking Lamotrigine.
• See a doctor as soon as possible or go to the nearest hospital for help.
A small number of people being treated with antiepileptics such as Lamotrigine have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
If you’re taking Lamotrigine for eplilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamotrigine. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or ifyou experience a severe seizure while you're taking Lamotrigine.
• Seeadoctorassoonaspossible
Lamotrigine should not be given to people aged under 18 years to treat bipolar disorder.
Medicines to treat depression and other mental problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.
Taking other medicines Tell your doctor or pharmacist if you’re taking other medicines, if you’ve taken any recently, or if you start taking new ones- these include herbal medicines or other medicines you bought withouta prescription.
If you are taking certain medicines, your doctor may need to check the dose of Lamotrigine. These include:
■ oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy.
■ lithium, used to treat mental health problems
■ bupropion, used to treat mental health problems or to stop smoking
• Tell your doctor if you are taking any of these.
Some medicines interact with Lamotrigine or make it more likely that you'll have side effects. These include:
valporate, used to treat epilepsy and mental health problems
carbamazepine, used to treat epilepsy and mental health problems phenytoin, primidone or phenobarbitone,
used to treat epilepsy
olanzapine, used to treat mental health problems
risperidone, used to treat mental health problems
rifampicin, which is an antibiotic atazanavir, lopinavir and ritonavir (medicines used to treat Human Immunodeficiency Virus (HIV) infection), hormonal contraceptives, such as the Pill (see below)
Tell your doctor if you are taking, or if you start or stop taking, any of these.
Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine works
Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamotrigine. If you plan to start using a hormonal contraceptive:
• Talk to your doctor, who will discuss suitable methods of contraception with you.
Lamotrigine can also affect the way hormonal contraceptives work, although it's unlikely to make them less effective. If you are using a hormonal contraceptive and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods:
• Tell your doctor. These may be signs that Lamotrigine is affecting the way your contraceptive is working.
Pregnancy and breastfeeding
• Talk to your doctor if you’re pregnant, if you might be pregnant, or if you’re planning to become pregnant.
You should not stop treatment for your epilepsy while you're pregnant; however, there is an increased risk of birth defects in babies whose mothers took Lamotrigine during pregnancy. These defects include cleft lip or cleft plate. Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.
Pregnancy may also alter the effectiveness of Lamotrigine, so your doctor may take samples of your blood to check the level of Lamotrigine, and may adjust your dose.
• Talk to your doctor if you’re breast feeding or planning to breast feed. The active ingredient of Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you're taking Lamotrigine, and will check your baby from time to time if you decide to breastfeed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Lamotrigine can cause dizziness and double vision.
• Don’t drive or operate machines unless you are sure you’re not affected.
If you have epilepsy, talk to your doctor about driving and using machines.
Tablets:
Important information about some of the ingredients of Lamotrigine
Lamotrigine tablet contains a source of phenylalanine. May be harmful for people with phenylketonuria.
3. Howtotake lamotrigine
Always use Lamotrigine exactly as your doctor has told you to. Check with your doctor or pharmacist if you're not sure.
Howmuch Lamotrigine to take
It may take a while to find the best dose of Lamotrigine for you. The dose you take will depend on:
• yourage
• whetheryou are taking Lamotrigine with other medicines
• whetheryou have problems with your kidneys or liver.
Your doctor will start you on a low dose, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose). Never take more Lamotrigine than your doctor tells you to.
The usual effective dose of Lamotrigine for adults and children aged over 12 years is between 100mg and 400mg each day.
For children aged 2 to 12 years, the effective dose depends on their body weight- usually, it's between 1mg and 15mg for each kilogram of the child's weight, up to a maxiumum of400mg daily.
Howto take your dose of Lamotrigine
Tablets:
Take your dose of Lamotrigine once or twice a day, as your doctor advises. You can take it with or without food.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment.
• Swallow your tablets whole. Don't break, chew or crush them.
• Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
Dispersible/Chewable tablets Take your dose of Lamotrigine once or twice a day, as your doctor advises. You can take it with or without food.
Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment.
You can take Lamotrigine Dispersible/Chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water.
Ifyou chewthe tablet:
You may need to drink a little more water at the same time to help the tablet dissolve in your mouth. Then drink some more water to make sure you have swallowed all the medicine.
To make a liquid medicine:
Put the tablet in a glass with at least enough water to coverthe whole tablet.
Either stir to dissolve, or wait for about a minute, until the tablet is fully dissolved.
Drink all the liquid.
Add a little more water to the glass and drink that, and to make sure you've taken all the medicine.
Ifyou take more Lamotrigine than you should:
If anyone takes too much Lamotrigine
• Contact a doctor or pharmacist
immediately. If possible, show them the Lamotrigine packet.
Someone who has taken too much Lamotrigine may have these symptoms:
• rapid, uncontrollable eye movements
(nystagmus)
• clumsiness and lack of co-ordination,
affecting their balance (ataxia)
• loss of consciousness or coma
If you forget to take Lamotrigine
Don’t take extra tablets or a double dose to
make up for a forgotten dose.
If you have missed taking a dose of Lamotrigine:
• Ask your doctor for advice on how to start taking it again. It's important that you do this.
Don’t stop taking Lamotrigine without advice.
Take Lamotrigine for as long as your doctor recommends. Don't stop unless your doctor advises you to.
Ifyou are taking Lamotrigine for epilepsy
To stop taking Lamotrigine, it is important that your dose is reduced gradually , over about 2 weeks. Ifyou suddenly stop taking Lamotrigine, your epilepsy may come back or get worse.
If you are taking Lamotrigine for bipolar disorder
Lamotrigine may take some time to work, so you are unlikely to feel better straight away. Ifyou stop taking Lamotrigine, yourdose will not need to be reduced gradually. But you should still talk to your doctorfirst, ifyou want to stop taking Lamotrigine.
4. Possible side effects
Like all medicines, Lamotrigine can cause side effects, but not everyone gets them.
Allergic reaction or potentially serious skin reaction: get a doctor’s help straight away
A small number of people taking Lamotrigine get an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening, problems if they are not treated. Symptoms of these reactions include:
• skin rashes or redness including a rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens-Johnson syndrome); a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal nercolysis)
■ a sore mouth or eyes
• a high temperature (fever), flu-like symptoms ordrowsiness
■ swelling around your face, or swollen glands in your neck, armpit or groin
■ unexpected bleeding or bruising, or your fingers turning blue
• a sore throat, or more infections (such as colds) than usual.
In many cases, these symptoms will be signs of serious side effects. But you must be aware that they are potentially serious- so, if you notice any of these symptoms:
• See a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine.
Very common side effects
These may affect more than 1 in 10 people:
• headache
• feeling dizzy
• feeling sleepy or drowsy
• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision
• feeling sickfnauseaj or being sick (vomiting)
• skin rash
Common side effects
These may affect uptol in 10 people:
• aggression or irritability
• rapid, uncontrollable eye movements (nystagmus)
• shaking or tremors
• difficulty in sleeping
• diarrhoea
• dry mouth
• feeling tired
• pain in your back orjoints, or elsewhere.
Rare side effects
These may affect up to 1 in 1,000 people:
• itchy eyes, with discharge and crusty eylids (conjunctivitis)
Very rare side effects
These may include up to 1 in 10,000 people:
• hallucinations ('seeing' or 'hearing' things that aren't really there)
• confusion oragitation
• feeling 'wobbly' or unsteady when you move about
• uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness
• in people who already have epilepsy, seizures happening more often
• changes in liver function, which will show up in blood tests, or liverfailure
• changes which may show up in blood tests-including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopoenia, neutropenia, agranulocytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
• a disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)
• a high temperature (fever)
• swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy)
• in people who already have Parkinson's disease, worsening of the symptoms.
Not known side effects: (frequency cannot be estimated from the available data)
• fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. These symptoms may be due to an infection around the brain or spinal cord (aseptic meningitis).
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist ifyou are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
Ifyou get side effects
• If any of the side effects becomes severe or troublesome, or ifyou notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) orfill in a paper form available from your local pharmacy.
5. How to store Lamotrigine
Keep out of the reach and sight of children.
Do not take after the expiry date on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package, in order to protect from moisture
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
Any unused product or waste material should be disposed of in accordance with local requirements.
6. Further information What Lamotrigine contains
The active substance is lamotrigine
Each dispersible tablet contains 25mg lamotrigine. Each dispersible tablet contains 50mg lamotrigine. Each dispersible tablet contains 100mg lamotrigine.
Each dispersible tablet contains 200mg lamotrigine.
The other ingredients are:Microcrystalline Cellulose, Calcium carbonate, Maltodextrin, Crospovidone, Povidone K30, Aspartame (E951), Low substituted Hydroxypropylcellulose, Mixed Berries flavour (Contains flavouring substances, maltodextrin and glyceryl triacetate), Magnesium stearate, Colloidal anhydrous silica Talc
What Lamotrigine looks like and contents of the pack
Dispersible tablet
Lamotrigine Ranbaxy 25mg Dispersible Tablets are white to off white round tablets, debossed with 'LI2' on one side and plain on the otherside.
Lamotrigine Ranbaxy 50mg Dispersible Tablets are white to off white round tablets, debossed with 'LI3' on one side and plain on the otherside.
Lamotrigine Ranbaxy 100mg Dispersible Tablets are white to off white round tablets, debossed with 'LI4' on one side and plain on the otherside.
Lamotrigine Ranbaxy 200mg Dispersible Tablets are white to off white round tablets, debossed with 'LI5' on one side and plain on the otherside.
Lamotrigine Ranbaxy 25/50/100/200 mg dispersible tablets are available in PVC/ PVdC/ Blister packs or polyamide /Aluminium / PVC /Aluminium foil blister containing 1,2,4,7,10,14,28,30, 56, 98 and 100 dispersible tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road London, W45YE United Kingdom
Manufacturer:
Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co Tipperary, Ireland
For any information about this medicinal product, or to obtain the leaflet in a different format please contactthe MarketingAuthorisation Holder
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This leaflet was last revised in January 2014. o
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