LAMOTRIGINE 5mg DISPERSIBLE TABLETS
LAMOTRIGINE 25mg DISPERSIBLE TABLETS
LAMOTRIGINE 50mg DISPERSIBLE TABLETS
LAMOTRIGINE 100mg DISPERSIBLE TABLETS
LAMOTRIGINE 200mg DISPERSIBLE TABLETS
Lamotrigine
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, ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it 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.
In this leaflet:
- 1. What Lamotrigine Dispersible Tablets are and what they are used for
- 2. Before you take Lamotrigine Dispersible Tablets
- 3. How to take Lamotrigine Dispersible Tablets
- 4. Possible side-effects
- 5. How to store Lamotrigine Dispersible Tablets
- 6. Further information
What Lamotrigine Dispersible Tablets Are And What They Are Used For
Your medicine is called Lamotrigine Dispersible Tablets.
The active ingredient is Lamotrigine. Lamotrigine belong to a group of medicines called anticonvulsants (antiepileptics) . Lamotrigine is used to treat the following types of seizures (fits or convulsions) due to bursts of abnormal electrical activity in the brain:
- Simple partial seizures (in which consciousness is retained) that affect one side of the brain
- Complex partial seizures (in which consciousness is impaired or lost) that affect one side of the brain
- Generalised tonic-clonic seizures (loss of consciousness, generalised muscle contraction [tonic] followed by shaking or convulsions [clonic]) that affect both sides of the brain
- Seizures associated with Lennox-Gastaut Syndrome an uncommon form of epilepsy with variable symptoms affecting a small proportion of children with epilepsy.
Your medicine may be used on its own to treat adults and children over 12 years.
Your medicine can also be used in combination with other anti-epileptic medicines in both adults and children age 2 years and over.
Before You Take Lamotrigine Dispersible Tablets
This medicine suits most people, but there are a few who should not take it, or who need to ask their doctor before doing so.
Do not use these tablets:
- If you are allergic to lamotrigine or any of the other ingredients in Lamotrigine Dispersible Tablets listed in Section 6.
Take special care with these tablets:
If any of the following applies to you (or if you are unsure if they apply) speak to your doctor before taking these tablets:
- Are you pregnant, trying to become pregnant or breast-feeding?
- Have you ever had a rash during previous treatment with lamotrigine?
- Are you taking any other medicines?
- Do you have a liver or kidney disease?
- Do you suffer from Parkinson's disease?
Thoughts of harming yourself or suicide
A small number of people being treated with anti-epileptics such as Lamotrigine Dispersible Tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact you doctor.
Taking these tablets and Contraceptives:
If you are a woman who is starting treatment with these tablets and you are already using a hormonal contraceptive (e.g."the pill"), the method of contraception you use should be reviewed by your doctor. This is because non-hormonal methods of contraception should be used, and a hormonal contraceptive (e.g."the pill") should only be used as the sole method of contraception if there is no other suitable alternative.
If you are already taking these tablets (lamotrigine) and intend to start or stop taking hormonal contraceptives (e.g. "the pill"), you should discuss this with your doctor, who may need to change your dose of these tablets. This medicine may reduce the ability of hormonal contraceptives (e.g. "the pill") to work.
Although not always seen, if you have any changes in your menstrual pattern (e.g. breakthrough bleeding or spotting) contact your doctor as soon as possible as this may be a sign of reduced effectiveness of hormonal contraceptives (e.g. "the pill").
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking the following medicines:
- any form of hormonal contraceptive (e.g."the pill"). See "Taking these tablets and Contraceptives" for more information.
- hormone replacement therapy (HRT)
- valproate, carbamazepine, phenytoin, phenobarbital, primidone or rifampicin.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking these tablets if you are pregnant, trying to become pregnant or if you are breast-feeding.
Driving and using machinery
Some people experience side-effects from lamotrigine that can affect their ability to drive or use machinery. It is important to talk to your doctor first before driving or using machinery.
How To Take Lamotrigine Dispersible Tablets
Please note: Your doctor may give you different instructions to those written below.
It is important to take your medicine in the way your doctor has told you to; if you are unsure, always check with your doctor. The dose your doctor will prescribe for you depends on whether you are taking any other medicines and if so which ones. This is especially important if you are taking any medicine containing valproate.
The pharmacist's label on your pack should tell you how many tablets to take and how often to take them. If the label doesn't state this, or if you are not sure, ask your doctor or pharmacist.
Taking the tablet:
The tablet can either be swallowed whole with a little water or it can be chewed or dissolved into a little water to form a liquid.
If the tablet is chewed, you may need to drink a small amount of water at the same time. This is because the tablet needs water when dissolving in the mouth. Then sip a little more water to make sure all of the medicine has been taken.
If you want to make the liquid medicine, add the tablet to a little water in a glass.
Make sure there is enough water to cover the tablet. Leave for about one minute for the tablet to dissolve and then drink the liquid. Add a little more water and drink this to make sure that you have taken all of the medicine.
For adults and children over 12 years: The usual dose used to control epilepsy is between 100mg and 400mg taken once daily or in two divided doses. When you first start taking these tablets, your doctor will prescribe a much lower dose than this and will then increase your dose gradually over a few weeks.
For children between the ages of 2 and 12 years: The usual dose used to control epilepsy is between 1mg and 15mg per kilogram of the child's body weight, taken once daily or in two divided doses. When your child first starts taking these tablets, your doctor will prescribe a much lower dose than this for your child and will then increase it gradually over a few weeks.
For children under 2 years: These tablets are not recommended for use.
If you or your child has a liver disease your doctor may prescribe less than the recommended dose, depending on how severe the liver condition is.
If you take more of these tablets than you should or if someone else takes your medicine by mistake, contact your doctor or go to your nearest casualty department immediately.
If you forget to take a dose of your medicine, take another dose as soon as you remember and then go on as before. Do not double the dose to make up for a missed one. If you are at all concerned about this consult your doctor or pharmacist.
You should not stop taking these tablets suddenly. Talk to your doctor first before stopping your medicine.
Possible Side-Effects
Like all medicines, these tablets can cause side-effects, although not everybody gets them.
If any of the following happen, they might be serious, so tell your doctor immediately or go to the casualty department at your nearest hospital:
- An allergic reaction with symptoms such as rash, swelling and/or a sore mouth or eyes
- fever
- facial swelling
- swollen glands
- symptoms such as yellowing of the skin, itching and abdominal pain and/or tenderness, which may be accompanied by feeling sick and generally unwell and indicate that the function of your liver might have been affected
The incidence of serious skin rashes in adults and children over the age of 12 is 1 in 1000. Parents should be aware that serious skin rashes are more common in children under the age of 12.
Tell your doctor as soon as possible if you notice any of the following effects:
- blurred vision, double vission, redness of the eyes (conjunctivitis), dizziness, headache, difficulties in sleeping, feeling or being sick, diarrhoea, hallucinations, feeling irritable, aggressive, agitated or confused;
- unsteadiness or loss of co-ordination when you walk;
- if you have Parkinson's disease, any worsening of your symptoms such as shaking of the arms or legs, rolling of the eyes or a chewing movement of the mouth;
- unusual movements that you can't control such as irregular jerking or shaking of the arms or legs;
- if your seizures become more frequent.
- if your epilepsy gets worse, particularly during the first month's treatment with these tablets.
- if you start feeling very tired, if you get any unexpected bruising or bleeding, if you start getting more infections (e.g. colds) than usual, or if you develop a sore throat.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Lamotrigine Dispersible Tablets
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use these tablets after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Any unused medicines should be returned to your pharmacist.
Further Information
What these tablets contain
Each tablet contains 5mg, 25mg, 50mg, 100mg, or 200mg of the active ingredient Lamotrigine.
The other ingredients are crospovidone, acesulfame potassium, orange flavour, mannitol, silica colloidal anhydrous and sodium stearyl fumarate.
What these tablets look like and contents of the pack
All the tablets are white to off-white, round tablets. The 25mg, 50mg, 100mg and 200mg tablets have an embossment ‘25’, '50', '100' and '200' on one side respectively.
The tablets are packed in blisters which are within a box containing 28, 30 or 56 tablets in a pack. Not all pack sizes may be marketed.
Marketing Authorization holder/Manufacturer
This leaflet was last approved in March 2009.
1249340112-C
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