amneal*

PHARMACEUTICALS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamotrigine Amneal 100 mg 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 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.

In this leaflet:

1.    What Lamotrigine Amneal is and what it is used for

2.    Before you take Lamotrigine Amneal

3.    How to take Lamotrigine Amneal

4.    Possible side effects

5.    How to store Lamotrigine Amneal dispersible tablets

6.    Further information

1. WHAT LAMOTRIGINE AMNEAL IS AND WHAT IT IS USED FOR

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder.

Lamotrigine Amneal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).

•    For adults and children aged 13 years and over, Lamotrigine Amneal can be used on its own or with other medicines, to treat epilepsy. Lamotrigine Amneal 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 Amneal 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 Amneal 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 18 years and over, Lamotrigine Amneal 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 Amneal works in the brain to have this effect.

2. BEFORE YOU TAKE LAMOTRIGINE AMNEAL DO NOT take Lamotrigine Amneal dispersible tablets

•    if you are allergic (hypersensitive) to Lamotrigine Amneal or any of the other ingredients of Lamotrigine Amneal dispersible tablets (listed in section 6).

If this applies to you:

^ Tell your doctor, and don’t take Lamotrigine Amneal dispersible tablets.

Take special care with Lamotrigine Amneal Important information about potentially serious reactions:

A small number of people taking Lamotrigine Amneal get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Lamotrigine Amneal dispersible tablets:

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) 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.

•    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. 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 with the use of Lamotrigine you must not be re-started on Lamotrigine at any time.

•    If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

^ See also section 4 of this leaflet under ‘Potentially serious reactions: get a doctor’s help straightaway’.

Your doctor needs to know before you take Lamotrigine Amneal:

•    if you have any kidney problems

•    if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or 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 the dose, or that Lamotrigine Amneal dispersible tablets are not suitable for you.

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. If you 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

•    if you are under 25 years old.

If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you’re taking Lamotrigine Amneal:

^ 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 also had thoughts of harming or killing themselves. If any time you have these thoughts, immediately contact your doctor.

If you’re taking Lamotrigine Amneal for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking Lamotrigine Amneal. 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 Amneal:

^ See a doctor as soon as possible.

Lamotrigine Amneal should not be given to people aged under 18 years to treat bipolar disorder.

Medicines to treat depression and other mental health 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 any other medicines, have taken any recently, or start taking new ones — these include herbal medicines or other medicines you bought without a prescription.

Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamotrigine Amneal. These medicines include:

•    oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy

•    lithium or olanzapine, 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 Amneal or make it more likely that people will 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 phenobarbitone, used to treat epilepsy

•    risperidone, used to treat mental health problems

•    rifampicin, which is an antibiotic

•    medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)

•    hormonal contraceptives, such as the Pill (see below),

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

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine Amneal 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 Amneal. If you are using a hormonal contraceptive, or if you plan to start using one:

^ Talk to your doctor, who will discuss suitable methods of contraception with you.

Lamotrigine Amneal 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 Amneal is affecting the way your contraceptive is working.

Pregnancy and breast-feeding

There may be an increased risk of birth defects in babies whose mothers took Lamotrigine Amneal 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 Amneal, so you may need blood tests and your dose of Lamotrigine Amneal may be adjusted.

^ 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 without discussing this with your doctor. This is particularly important if you have epilepsy.

^ Talk to your doctor if you’re breast feeding or planning to breast-feed. The active ingredient 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 Amneal, and will check your baby from time to time if you decide to breast-feed.

Driving and using machines

Lamotrigine Amneal 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.

3. HOW TO TAKE LAMOTRIGINE AMNEAL

Always take Lamotrigine Amneal exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re not sure.

How much Lamotrigine Amneal to take

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

•    your age

•    whether you are taking Lamotrigine Amneal with other medicines

•    whether you have any kidney or liver problems.

Your doctor will prescribe a low dose to start, 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 Amneal than your doctor tells you to.

The usual effective dose of Lamotrigine Amneal for adults and children aged 13 years or over 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 Amneal is not recommended for children aged under 2 years.

How to take your dose of Lamotrigine Amneal

Take your dose of Lamotrigine Amneal once or twice a day, as your doctor advises. It can be taken 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.

Lamotrigine Amneal dispersible tablets can either be swallowed whole with a little water, chewed, or mixed with water to make a liquid medicine:

To chew the tablet:

You may need to drink a little water at the same time to help the tablet dissolve in the mouth. Then drink some more water to make sure all the medicine has been swallowed.

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 no medicine is left in the glass. If you take more Lamotrigine Amneal than you should

^ Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine Amneal packet.

Someone who has taken too much Lamotrigine Amneal 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 Amneal

Don’t take extra tablets or a double dose to make up for a forgotten dose.

^ Ask your doctor for advice on how to start taking it again. It’s important that you do this. Don’t stop taking Lamotrigine Amneal without advice

Lamotrigine Amneal must be taken for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you are taking Lamotrigine Amneal for epilepsy

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

If you are taking Lamotrigine Amneal for bipolar disorder

Lamotrigine Amneal may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine Amneal, your dose will not need to be reduced gradually. But you should still talk to your doctor first, if you want to stop taking Lamotrigine Amneal.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lamotrigine Amneal can cause side effects, but not everyone gets them.

Potentially serious reactions: get a doctor’s help straight away

A small number of people taking Lamotrigine Amneal get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated.

These symptoms are more likely to happen during the first few months of treatment with Lamotrigine Amneal, especially if the starting dose is too high or if the dose increased too quickly, or if Lamotrigine Amneal is taken with another medicine called valproate. Some of the symptoms are more common in children, so parents should be especially careful to watch out for them.

Symptoms of these reactions include:

•    skin rashes or redness, which may develop into severe 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 necrolysid)

•    a sore mouth or eyes

•    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 the fingers turning blue

•    a sore throat, or more infections (such as colds) than usual.

In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms:

^ Contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine Amneal.

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

•    dry mouth

•    feeling tired

•    pain in your back or joints, or elsewhere.

Rare side effects

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

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

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported (see section 2 and at the beginning of section 4).

Very rare side effects

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

•    Potentially life-threatening skin rashes (toxic epidermal necrolysis) have been reported (see section 2 and at the beginning of section 4).

•    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 (leucopenia, neutropenia, agranulo-cytosis), 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 serious 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.

Possible risk of bone disorders

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.

Other side effects

Other side effects have occurred in a small number of people but their exact frequency is unknown:

•    A group of symptoms together including:

- fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light.

This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis).

If you get side effects

If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LAMOTRIGINE AMNEAL DISPERSIBLE TABLETS

Keep out of the reach and sight of children.

Do not use Lamotrigine Amneal dispersible tablets after the expiry date, which is stated on the carton after the EXP The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. FURTHER INFORMATION

What Lamotrigine Amneal dispersible tablets contain

-    The active substance is lamotrigine. Each dispersible tablet contains 100 mg lamotrigine.

-    The other ingredients are cellulose microcrystalline, magnesium carbonate heavy, polacrilin potassium, sucralose, povidone (K-30), magnesium stearate, black currant flavor (maltodextrin, artificial flavors, triacetin, acetic acid & caramel color).

What Lamotrigine Amneal dispersible tablets looks like and contents of the pack

Dispersible tablet.

Lamotrigine Amneal 100 mg dispersible tablets

White to off-white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘78’ on flat side.

Lamotrigine Amneal dispersible tablets are available in:

-    PVC/Aclar/Al blister:

Pack sizes: 7, 10, 14, 20, 21,28, 30, 40, 42, 50, 56, 60, 90, 98, 100, 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 07/2014.