iMedi.co.uk

Lamotrigine Teva 5mg Dispersible Tablets

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 484



LAMOTRIGINE TEVA 5 mg, 25 mg AND 100 mg DISPERSIBLE TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

•    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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET

1.    What Lamotrigine is and what it is used for

2.    What you need to know before you take Lamotrigine

3.    How to take Lamotrigine

4.    Possible side effects

5.    How to store Lamotrigine

6.    Contents of the pack and other information

WHAT LAMOTRIGINE IS AND WHAT IT IS USED FOR

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat epilepsy.

Lamotrigine treats epilepsy by blocking the 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.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMOTRIGINE

Important information about potentially life-threatening reactions

A small number of people taking Lamotrigine have experienced an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to know the symptoms to look out for while you are taking Lamotrigine.

Read the description of these symptoms in Section 4 of this leaflet

under 'Potentially life-threatening reactions: get a doctor's help straight away'.

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 Warnings and precautions

Talk to your doctor before taking Lamotrigine if you:

   have problems with your kidneys

•    have ever developed a rash when you've taken lamotrigine or other medicines for epilepsy

   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 for you.

Watch out for important symptoms If you develop a rash or these skin symptoms, stop taking Lamotrigine, seek urgent advice from a doctor and tell him that you are taking this medicine:

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS) have been reported with the use of Lamotrigine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. For more information on these reactions,

•    please read section 4 (Possible side effects).

•    Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

•    These potentially life-threatening skin rashes are often accompanied by flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. The rash may progress to widespread blistering or peeling of the skin.

•    The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.

•    If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or a drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of Lamotrigine, you must not be re-started on Lamotrigine at any time.

•    a high temperature (fever)

•    drowsiness

These symptoms are more likely to happen during the first few months of treatment with Lamotrigine, especially if you start on too high a dose or if your dose is increased too quickly, or if you're taking Lamotrigine with another medicine called valproate. 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. 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.

Thoughts of harming yourself or suicide

If you 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 anti-epileptics such as Lamotrigine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Risk of increased or severe seizures

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 if you experience a severe seizure while you're taking Lamotrigine, see a doctor as soon as possible.

Other medicines and Lamotrigine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines bought without a prescription.

Tell your doctor or pharmacist if you're taking, have recently taken or might take any of the following:-

   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

If you start or stop taking certain medicines whilst you are taking Lamotrigine, your doctor may need to check your dose of Lamotrigine. These include:

•    atazanavir in combination with ritonavir

•    lopinavir in combination with ritonavir

Tell your doctor if you start or stop taking any of these.

Some medicines interact with Lamotrigine or make it more likely that you'll have side effects. These include:

   valproate, used to treat epilepsy and mental health problems

   carbamazepine, used to treat epilepsy and mental health problems

   phenytoin, primidone or phenobarbital, used to treat epilepsy

   olanzapine, used to treat mental health problems

   risperidone, used to treat mental health problems

   rifampicin, which is an antibiotic

   a combination of lopinavir and ritonavir, 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, breast-feeding and fertility

•    If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 palate. 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 breast feed.

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.

a HOW TO TAKE LAMOTRIGINE

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

How much Lamotrigine to take

It may take a while to find the best dose of Lamotrigine for you. The dose you take will depend on:

•    your age

•    whether you are taking Lamotrigine with other medicines

•    whether you have problems with your kidneys or liver.

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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 recommended effective dose of Lamotrigine for adults and children aged over 12 years is between 100 mg and 400 mg each day.

For children aged 2 to 12 years, the effective dose depends on their body weight - usually, it's between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum of 400 mg daily.

Lamotrigine is not recommended for children aged under 2 years. How to take your dose of Lamotrigine Dispersible 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.

•    You can take Lamotrigine dispersible tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water.

   Always take the full dose that your doctor has prescribed.

Never take only part of a tablet.

If you chew the tablet:

You may need to drink a little 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 cover the 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, to make sure you've taken all the medicine.

If you 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 any of 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 this medicine, 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.

To stop taking Lamotrigine, it is important that your dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine, your epilepsy may come back or get worse.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement (DRESS).

•    Ulcers in the mouth,throat, nose or genitals

   a sore mouth or eyes (conjunctivitis)

   a high temperature (fever), flu-like symptoms or drowsiness

   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

•    increased levels of liver enzymes seen in blood tests

•    an increase in a type of white blood cell (eosinophils)

•    enlarged lymph nodes

•    involvement of the organs of the body including liver and kidneys.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) , or extended rashes with liver, blood and other body organs involvement (DRESS) have been reported (see section 2).

These are very serious but rare or very rare side effects. You may need urgent medical attention or hospitalisation. In many cases, your symptoms will be signs of less 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.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

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 sick (nausea) or being sick (vomiting)

•    skin rash.

Common side effects

These may affect up to 1 in 10 people:

•    aggression or irritability

•    rapid, uncontrollable eye movements (nystagmus)

•    shaking or tremors

•    difficulty in sleeping

•    diarrhoea

•    feeling tired

Rare side effects

These may affect up to 1 in 1,000 people:

•    itchy eyes, with discharge and crusty eyelids (conjunctivitis)

Very rare side effects

These may affect up to 1 in 10,000 people:

•    hallucinations ('seeing' or 'hearing' things that aren't really there)

•    confusion or agitation

•    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 liver failure

•    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

•    in people who already have Parkinson's disease, worsening of the symptoms.

Frequency not known

The frequency of these side effects cannot be estimated from the

currently available data:

•    There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

•    swollen glands (lymphadenopathy)

•    aseptic meningitis

•    DRESS

Reporting of side effects:

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine

HOW TO STORE LAMOTRIGINE

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original blister pack to protect from moisture.

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

^ CONTENTS OF THE PACK AND OTHER INFORMATION

What Lamotrigine Teva Dispersible Tablets contain:

•    The active ingredient is lamotrigine.

•    Other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, pregelatinised starch, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate, saccharin sodium and artificial cherry flavour.

What Lamotrigine Teva Dispersible Tablets look like and contents

of the pack:

•    The 5 mg tablets are white to off white, round tablets, number "93" on one side and "688" on the other.

•    The 25 mg tablets are white to off white, oval tablets, number "93" on one side and "132" on the other.

•    The 100 mg tablets are white to off white, round tablets, number "100" on one side and "DLT" on the other.

•    The 5 mg tablets are available in pack sizes of 28, 30, 50, 56, 60 and 90.

•    The 25 mg tablets are available in pack sizes of 30, 50, 56, 60 and 90.

•    The 100 mg tablets are available in pack sizes of 28 30, 50, 56, 100 and 200.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for

manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: July 2015

PL 00289/0505-0506, PL00289/0508

84117-ZB 323 x 160mm

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